FDA product code · General, Plastic Surgery
GEIElectrosurgical, Cutting & Coagulation & Accessories
Product code GEI covers Electrosurgical, Cutting & Coagulation & Accessories, a Class II device regulated under 21 CFR 878.4400. FDA has cleared 2,312 devices in this code, 59 of them in the last 12 months. Median review time across the 2,312 most recent decisions is 83 days. openFDA lists 643 recall records against this code.
Updated · ingest status · JSON
- Class
- Class II
- Regulation
- 21 CFR 878.4400
- Review panel
- General, Plastic Surgery
- Clearances
- 2,312
What is happening in GEI right now?
GEI (Electrosurgical, Cutting & Coagulation & Accessories) has four findings, most consequential first. 5 recalls opened in the last 12 months and not yet terminated (Class II) (Z-2865-2026, Z-2866-2026, Z-2741-2026, Z-1851-2026, Z-1852-2026). 16 first-time filers in the last 12 months, including Gimmi GmbH and Cynosure Lutronic Technology Corporation (K261179, K253484, K253634, K253803, K253134). Clearances are running 63% slower — a median 135 days over the last 12 months against 83 days all-time (elapsed calendar days, not FDA review days) (GEI:review_time:12m). The code is crowded, scoring 100 of 100 — 697 companies hold a clearance here and 59 arrived in the last 12 months (GEI:crowding).
| Finding | How much it matters | FDA records |
|---|---|---|
| Recall | Class II recall | Z-2865-2026, Z-2866-2026, Z-2741-2026, Z-1851-2026, Z-1852-2026 |
| New entrant | Worth knowing | K261179, K253484, K253634, K253803, K253134 |
| Review time | Context | GEI:review_time:12m |
| Crowding | Context | GEI:crowding |
Sources checked: predicate ancestry, recalls, adverse events, new entrants, review time, crowding. Composed . Every finding carries the record ids it was derived from; nothing here is an estimate.
What does product code GEI cover?
GEI is FDA's product code for Electrosurgical, Cutting & Coagulation & Accessories, a Class II device regulated under 21 CFR 878.4400.
Validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission if the device is reusable and has specific design features (please refer to Table 2 of 82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).
Source: openFDA device/classification · record GEI · retrieved
How many devices has FDA cleared in GEI?
FDA has cleared 2,312 devices under product code GEI since the 510(k) programme began in 1976, 59 of them in the last 12 months.
Source: openFDA device/510k · retrieved
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261179 | AlphaTriPart - Monopolar MIC Instruments | Gimmi GmbH | |
| K253504 | Volnewmer | Classys, Inc. | |
| K254056 | THUNDERBEAT 5 mm, 45 cm, Front-actuated Grip Type S (TB-0545FCS); THUNDERBEAT 5 mm, 35 cm, Front-actuated Grip Type S (TB-0535FCS); THUNDERBEAT 5 mm, 20 cm, Front-actuated Grip Type S (TB-0520FCS) | Olympus Medical Systems Corp. | |
| K253484 | LUTRONIC GENIUS | Cynosure Lutronic Technology Corporation | |
| K251492 | Irrigation Tubing Bipolar Cord Set | New Deantronics Taiwan , Ltd. | |
| K260636 | Remanufactured LigaSure XP Maryland Jaw Sealer/Divider Without Nano-coating | Stryker Sustainability Solutions | |
| K253634 | CoolSeal Generator® (CSL-200-90) | Hologic, Inc. | |
| K261833 | NEUROMARK System (NMK00301) | Neurent Medical , Ltd. | |
| K253165 | LAP-iX2N | Sejong Medical Co., Ltd. | |
| K253656 | OsteoCool RF Ablation System; OsteoCool 2.0 RF Ablation System | Medtronic Sofamor Danek USA, Inc. |
How long does FDA review take for GEI?
The median FDA review time for GEI is 83 days, measured across the 2,312 most recent decisions with both a received date and a decision date.
Review time here is decision date minus date received, as published by FDA. It is elapsed calendar time, not FDA review days — the two differ whenever the agency stops the clock for an additional information request.
Source: openFDA device/510k · retrieved
Are there recalls in GEI?
openFDA lists 643 recall records against product code GEI. A recall record covers one firm's corrective action and may span many device lots.
Z-2865-2026Open, ClassifiedStryker Corporation
There has been an increased amount in reported complaints consistently describing leaking from the handpiece during use.
Z-2866-2026Open, ClassifiedStryker Corporation
There has been an increased amount in reported complaints consistently describing leaking from the handpiece during use.
Z-2741-2026Open, ClassifiedMaquet Cardiovascular, LLC
Getinge identified that Vasoview Hemopro 2 devices from Lot 3000547797 were exposed to an out-of-specification sterilization dose during a gamma sterilization run (Run ID 1183-28782A) performed by STERIS at its Whippany, NJ facility between March 31 and April 1 of 2026.
Z-1851-2026Open, ClassifiedOlympus Corporation of the Americas
Potential for detachment of a distal tip component of the device during use.
Z-1852-2026Open, ClassifiedOlympus Corporation of the Americas
Potential for detachment of a distal tip component of the device during use.
Showing the 5 most recently initiated of 643. Recall class comes from openFDA's enforcement endpoint, which does not carry every recall — where it is missing, none is shown rather than guessed. Status is FDA's own wording; a terminated recall is a closed one, and the total spans the code's whole history, not just what is open today.
Source: openFDA device/recall · retrieved
How many adverse events are reported for GEI?
MAUDE holds 22,525 adverse-event reports naming product code GEI, 4,957 of them received in the last 12 months.
MAUDE reports are submitted by manufacturers, importers, user facilities and the public. They are unverified, and a report is not proof that the device caused the event.
Source: openFDA device/event · retrieved
Is adverse-event reporting in GEI unusual?
One month sits above GEI's own expected range: 1 June 2025.
| Month | Reports | Expected | Verdict |
|---|---|---|---|
| 592 | Insufficient history | No expected range — too little history | |
| 543 | Insufficient history | No expected range — too little history | |
| 625 | Insufficient history | No expected range — too little history | |
| 511 | Insufficient history | No expected range — too little history | |
| 616 | Insufficient history | No expected range — too little history | |
| 597 | Insufficient history | No expected range — too little history | |
| 510 | Insufficient history | No expected range — too little history | |
| 545 | Insufficient history | No expected range — too little history | |
| 527 | Insufficient history | No expected range — too little history | |
| 767 | Insufficient history | No expected range — too little history | |
| 653 | Insufficient history | No expected range — too little history | |
| 777 | Insufficient history | No expected range — too little history | |
| 739 | Insufficient history | No expected range — too little history | |
| 706 | Insufficient history | No expected range — too little history | |
| 624 | Insufficient history | No expected range — too little history | |
| 666 | Insufficient history | No expected range — too little history | |
| 613 | Insufficient history | No expected range — too little history | |
| 623 | Insufficient history | No expected range — too little history | |
| 631 | Insufficient history | No expected range — too little history | |
| 537 | Insufficient history | No expected range — too little history | |
| 562 | Insufficient history | No expected range — too little history | |
| 536 | 347–744 | Within expected (347–744) | |
| 472 | 306–637 | Within expected (306–637) | |
| 563 | 343–717 | Within expected (343–717) | |
| 679 | 406–709 | Within expected (406–709) | |
| 533 | 441–670 | Within expected (441–670) | |
| 693 | 463–675 | Above expected (463–675) | |
| 695 | 758–1,145 | Below expected (758–1,145) | |
| 618 | 494–827 | Within expected (494–827) | |
| 621 | 506–858 | Within expected (506–858) | |
| 700 | 481–836 | Within expected (481–836) | |
| 572 | 444–765 | Within expected (444–765) | |
| 743 | 485–833 | Within expected (485–833) | |
| 526 | 591–989 | Below expected (591–989) | |
| 652 | 388–815 | Within expected (388–815) | |
| 702 | 443–910 | Within expected (443–910) |
21 months do not have a full, unbroken year of history before them, so no expected range is shown for those. Insufficient history is reported as insufficient rather than as zero: an empty baseline would turn a gap in our data into a spike. Method: ewma_alpha_0.3_sd_2 corpus_adjusted. Counts are divided by the corpus-wide volume for that month before comparison, so a rise across all of MAUDE is not reported as a rise in GEI.
Who has entered GEI in the last year?
8 companies filed in GEI for the first time in the last 12 months.
| Company | First cleared | K-number |
|---|---|---|
| Gimmi GmbH | K261179 | |
| Cynosure Lutronic Technology Corporation | K253484 | |
| Hologic, Inc. | K253634 | |
| Lumenis Be, Inc. | K253803 | |
| Lagis Enterprise Co., Ltd. | K253134 | |
| Ascblue Corporation | K253777 | |
| Zhejiang shuyou Surgical Instrument Co., Ltd. | K260466 | |
| Prana Surgical | K253405 |
"First time" means their first clearance in this product code, not their first ever — an established manufacturer entering a new category is exactly the movement worth knowing about.
Source: openFDA device/510k · retrieved
What are the predicate devices in GEI?
FDA publishes no machine-readable predicate field, so no predicate chain is recorded for this code yet.
A predicate chain matters because a device inherits the safety history of what it was compared to. FDA publishes the chain only inside each 510(k) summary PDF, never as data — so where we have edges, they are read from those documents, and where we do not, we say so instead of showing an empty list.
Who files 510(k)s in GEI?
Across the 2,312 most recent decisions, these applicants filed most often in GEI.
| Applicant | Recent clearances |
|---|---|
| Arthrocare Corp. | 64 |
| Valleylab, Inc. | 60 |
| Conmedcorp | 43 |
| Megadyne Medical Products, Inc. | 32 |
| Aaron Medical Industries | 27 |
Applicant names above are exactly as FDA published them, so one company can appear under several spellings.
The same makers, after name resolution
3 companies in GEI file under more than one spelling. Resolving them to one identity — across all six datasets, not just this one — is what makes a joined count possible at all.
| Company | Clearances | FDA spellings merged |
|---|---|---|
| ArthroCare Corporation | 86 | 2 |
| Valleylab,A Division of Tyco Healthcare Group LP | 71 | 3 |
| Covidien | 40 | 3 |
Merges are measured against a hand-labelled sample and held above 98% precision; pairs the matcher is unsure of are queued for a person rather than merged. See DeviceSignal.
Source: openFDA device/510k · retrieved
Watch GEI
Get an email the morning anything changes in GEI — a new clearance, a recall, or an adverse-event spike above this code's own baseline.
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Data on this page comes from FDA's public openFDA API and is US public domain (CC0). DeviceSignal is an independent commercial service and is not affiliated with the U.S. Food and Drug Administration. Information only, not regulatory advice. Verify anything you rely on against open.fda.gov.