FDA product code · General, Plastic Surgery
GEHUnit, Cryosurgical, Accessories
Product code GEH covers Unit, Cryosurgical, Accessories, a Class II device regulated under 21 CFR 878.4350. FDA has cleared 263 devices in this code, 12 of them in the last 12 months. Median review time across the 263 most recent decisions is 88 days. openFDA lists 105 recall records against this code.
Updated · ingest status · JSON
- Class
- Class II
- Regulation
- 21 CFR 878.4350
- Review panel
- General, Plastic Surgery
- Clearances
- 263
What is happening in GEH right now?
GEH (Unit, Cryosurgical, Accessories) has four findings, most consequential first. 5 recalls opened in the last 12 months and not yet terminated (Class I, Class II) (Z-1566-2026, Z-1567-2026, Z-1568-2026, Z-2550-2025, Z-2551-2025). 3 first-time filers in the last 12 months, including Serpex Medical, Inc. and Medinice S.A (K261068, K251928, K250742). Clearances are running 67% faster — a median 29 days over the last 12 months against 88 days all-time (elapsed calendar days, not FDA review days) (GEH:review_time:12m). The code is crowded, scoring 85 of 100 — 98 companies hold a clearance here and 12 arrived in the last 12 months (GEH:crowding).
| Finding | How much it matters | FDA records |
|---|---|---|
| Recall | Class I recall | Z-1566-2026, Z-1567-2026, Z-1568-2026, Z-2550-2025, Z-2551-2025 |
| New entrant | Worth knowing | K261068, K251928, K250742 |
| Review time | Context | GEH:review_time:12m |
| Crowding | Context | GEH: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.
How many devices has FDA cleared in GEH?
FDA has cleared 263 devices under product code GEH since the 510(k) programme began in 1976, 12 of them in the last 12 months.
Source: openFDA device/510k · retrieved
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261068 | Maverix Cryo Biopsy Probe (MCB1000);Maverix Cryo Cartridge (CC1000) | Serpex Medical | |
| K261806 | ERBECRYO 2 Cryosurgical Unit and Accessories | Erbe Elektromedizin GmbH | |
| K253230 | ERBECRYO 2 Cryosurgical Unit and Accessories: ERBECRYO 2 cryosurgical unit; Erbe Flexible Cryoprobe | Erbe Elektromedizin GmbH | |
| K252198 | Advanced Cryo Skin Tag Remover (Advanced Skin Tag Remover) | Medical Brands Laboratories B.V. | |
| K260377 | XSense Cryoablation System with CryoProbes | IceCure Medical , Ltd. | |
| K251928 | CoolCryo - Cryoapplicator for cardiac cryoablation (CC01-01); CoolCryo - Control console for cardiac cryoablation with liquid nitrogen reservoir (CC01-21) | Medinice S.A. | |
| K251524 | Dr. Yglo Skin Tag Remover | Theotclab Healthcare B.V. | |
| K250742 | Focused Cryotherapy System | Focused Cryo, Inc. | |
| K253114 | TargetCool (RM-DT02W) | Recensmedical, Inc. | |
| K253000 | CryoFreeze Wart and Skin Tag Remover | Cryosurgery, Inc. |
How long does FDA review take for GEH?
The median FDA review time for GEH is 88 days, measured across the 263 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 GEH?
openFDA lists 105 recall records against product code GEH. A recall record covers one firm's corrective action and may span many device lots.
Z-1566-2026Open, ClassifiedErbe USA Inc
Probes may rupture/burst during activation
Z-1567-2026Open, ClassifiedErbe USA Inc
Probes may rupture/burst during activation
Z-1568-2026Open, ClassifiedErbe USA Inc
Probes may rupture/burst during activation
Z-2550-2025Open, ClassifiedBoston Scientific Corporation
Certain desiccant tube subassemblies were built with end caps that were not correctly tightened.
Z-2551-2025Open, ClassifiedBoston Scientific Corporation
Certain desiccant tube subassemblies were built with end caps that were not correctly tightened.
Showing the 5 most recently initiated of 105. 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 GEH?
MAUDE holds 508 adverse-event reports naming product code GEH, 161 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 GEH unusual?
2 months sit above GEH's own expected range: 1 May 2025, 1 August 2025.
| Month | Reports | Expected | Verdict |
|---|---|---|---|
| 16 | Insufficient history | No expected range — too little history | |
| 18 | Insufficient history | No expected range — too little history | |
| 15 | Insufficient history | No expected range — too little history | |
| 15 | Insufficient history | No expected range — too little history | |
| 10 | Insufficient history | No expected range — too little history | |
| 13 | Insufficient history | No expected range — too little history | |
| 7 | Insufficient history | No expected range — too little history | |
| 12 | Insufficient history | No expected range — too little history | |
| 10 | Insufficient history | No expected range — too little history | |
| 6 | Insufficient history | No expected range — too little history | |
| 13 | Insufficient history | No expected range — too little history | |
| 11 | Insufficient history | No expected range — too little history | |
| 4 | Insufficient history | No expected range — too little history | |
| 11 | Insufficient history | No expected range — too little history | |
| 20 | Insufficient history | No expected range — too little history | |
| 12 | Insufficient history | No expected range — too little history | |
| 16 | Insufficient history | No expected range — too little history | |
| 9 | Insufficient history | No expected range — too little history | |
| 10 | Insufficient history | No expected range — too little history | |
| 11 | Insufficient history | No expected range — too little history | |
| 18 | Insufficient history | No expected range — too little history | |
| 7 | 3–21 | Within expected (3–21) | |
| 9 | 2–17 | Within expected (2–17) | |
| 10 | 2–19 | Within expected (2–19) | |
| 11 | 1–19 | Within expected (1–19) | |
| 20 | 3–17 | Above expected (3–17) | |
| 4 | 4–23 | Below expected (4–23) | |
| 18 | 3–30 | Within expected (3–30) | |
| 25 | 3–23 | Above expected (3–23) | |
| 14 | 4–30 | Within expected (4–30) | |
| 10 | 4–29 | Within expected (4–29) | |
| 20 | 1–24 | Within expected (1–24) | |
| 23 | 3–30 | Within expected (3–30) | |
| 28 | 5–37 | Within expected (5–37) | |
| 23 | 6–33 | Within expected (6–33) | |
| 27 | 8–38 | Within expected (8–38) |
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 GEH.
Who has entered GEH in the last year?
3 companies filed in GEH for the first time in the last 12 months.
| Company | First cleared | K-number |
|---|---|---|
| Serpex Medical, Inc. | K261068 | |
| Medinice S.A. | K251928 | |
| Focused Cryo, Inc. | K250742 |
"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 GEH?
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 GEH?
Across the 263 most recent decisions, these applicants filed most often in GEH.
| Applicant | Recent clearances |
|---|---|
| Galil Medical , Ltd. | 22 |
| CSA Medical, Inc. | 14 |
| Endocare, Inc. | 13 |
| Cryomedical Sciences, Inc. | 9 |
| AtriCure, Inc. | 8 |
Applicant names above are exactly as FDA published them, so one company can appear under several spellings.
The same makers, after name resolution
One company in GEH files 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 |
|---|---|---|
| Galil Medical, Inc. | 29 | 2 |
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 GEH
Get an email the morning anything changes in GEH — 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.