FDA product code · Obstetrics/Gynecology
HETLaparoscope, Gynecologic (And Accessories)
Product code HET covers Laparoscope, Gynecologic (And Accessories), a Class II device regulated under 21 CFR 884.1720. FDA has cleared 338 devices in this code, 1 of them in the last 12 months. Median review time across the 338 most recent decisions is 150 days. openFDA lists 19 recall records against this code.
Updated · ingest status · JSON
- Class
- Class II
- Regulation
- 21 CFR 884.1720
- Review panel
- Obstetrics/Gynecology
- Clearances
- 338
What is happening in HET right now?
HET (Laparoscope, Gynecologic (And Accessories)): nothing changed in the six FDA sources we watch.
Checked predicate ancestry, recalls, adverse events, new entrants, review time, crowding. Nothing changed, so there is nothing here — which is the point. We only write when something did.
How many devices has FDA cleared in HET?
FDA has cleared 338 devices under product code HET since the 510(k) programme began in 1976, 1 of them in the last 12 months.
Source: openFDA device/510k · retrieved
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K250939 | SIRIUS Endoscope System (PR-SI-1230) | Precision Robotics (Hong Kong) Limited | |
| K243821 | i-Cut | A.M.I. Agency For Medical Innovations GmbH | |
| K221642 | SIRIUS Endoscope System | Precision Robotics (Hong Kong) Limited | |
| K210116 | Video Endoscopy System, 3D Video Endoscopy System | Surgnova Healthcare Technologies (Zhejiang) Co., Ltd. | |
| K201832 | Endoeye Flex Deflectable Videoscope Olympus LTF-S190-5 | Olympus Medical Systems Corp. | |
| K210104 | SurroundScope System | 270surgical , Ltd. | |
| K201617 | TipVision Videoscope System (TipVision VideoScope 0°/30°; EleVision HD 2 Camera Control Unit (CCU)) | Schoelly Fiberoptic GmbH | |
| K200216 | 4K UHD Camera System | Scivita Medical Technology Co., Ltd. | |
| K200638 | LAP-iX Suction Irrigation | Sejong Medical Co., Ltd. | |
| K190190 | WV1 Endoscope | 270surgical , Ltd. |
How long does FDA review take for HET?
The median FDA review time for HET is 150 days, measured across the 338 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 HET?
openFDA lists 19 recall records against product code HET. A recall record covers one firm's corrective action and may span many device lots.
Z-1473-2024Open, ClassifiedKarl Storz Endoscopy
Inadequate reprocessing validation evidence
Z-0644-2024Open, ClassifiedOlympus Corporation of the Americas
Instructions for Use-User Deviations related to the reprocessing of the videoscope detailed in the Reprocessing Manual Instructions. The steps are required for the proper reprocessing of these videoscopes
Z-0645-2024Open, ClassifiedOlympus Corporation of the Americas
Instructions for Use-User Deviations related to the reprocessing of the videoscope detailed in the Reprocessing Manual Instructions. The steps are required for the proper reprocessing of these videoscopes
Z-0697-2024Open, ClassifiedOlympus Corporation of the Americas
Reports of a pink or green coloration of the image. If the issue is encountered during a procedure, device exchange could potentially result in prolonged surgery; potential visual impacts mucosal injury or bleeding may occur.
Z-0573-2024Open, ClassifiedKarl Storz Endoscopy
The efficacy of the manual cleaning process cannot be assured for the affected injection needles intended for general surgery and visceral surgery, which if used, may expose the patient to a higher risk of infection.
Showing the 5 most recently initiated of 19. 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 HET?
MAUDE holds 9,778 adverse-event reports naming product code HET, 3,269 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 HET unusual?
One month sits above HET's own expected range: 1 December 2025.
| Month | Reports | Expected | Verdict |
|---|---|---|---|
| 73 | Insufficient history | No expected range — too little history | |
| 45 | Insufficient history | No expected range — too little history | |
| 83 | Insufficient history | No expected range — too little history | |
| 39 | Insufficient history | No expected range — too little history | |
| 69 | Insufficient history | No expected range — too little history | |
| 60 | Insufficient history | No expected range — too little history | |
| 66 | Insufficient history | No expected range — too little history | |
| 66 | Insufficient history | No expected range — too little history | |
| 62 | Insufficient history | No expected range — too little history | |
| 71 | Insufficient history | No expected range — too little history | |
| 53 | Insufficient history | No expected range — too little history | |
| 73 | Insufficient history | No expected range — too little history | |
| 206 | Insufficient history | No expected range — too little history | |
| 504 | Insufficient history | No expected range — too little history | |
| 423 | Insufficient history | No expected range — too little history | |
| 451 | Insufficient history | No expected range — too little history | |
| 309 | Insufficient history | No expected range — too little history | |
| 382 | Insufficient history | No expected range — too little history | |
| 357 | Insufficient history | No expected range — too little history | |
| 198 | Insufficient history | No expected range — too little history | |
| 469 | Insufficient history | No expected range — too little history | |
| 446 | 14–625 | Within expected (14–625) | |
| 370 | 57–565 | Within expected (57–565) | |
| 298 | 123–613 | Within expected (123–613) | |
| 361 | 166–555 | Within expected (166–555) | |
| 291 | 180–503 | Within expected (180–503) | |
| 278 | 182–494 | Within expected (182–494) | |
| 295 | 268–737 | Within expected (268–737) | |
| 332 | 134–527 | Within expected (134–527) | |
| 297 | 144–555 | Within expected (144–555) | |
| 369 | 121–541 | Within expected (121–541) | |
| 401 | 117–496 | Within expected (117–496) | |
| 652 | 188–562 | Above expected (188–562) | |
| 305 | 263–796 | Within expected (263–796) | |
| 368 | 167–614 | Within expected (167–614) | |
| 632 | 190–647 | Within expected (190–647) |
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 HET.
What are the predicate devices in HET?
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 HET?
Across the 338 most recent decisions, these applicants filed most often in HET.
| Applicant | Recent clearances |
|---|---|
| KARL STORZ Endoscopy-America, Inc. | 29 |
| Dixon Medical, Inc. | 12 |
| ETHICON, Inc. | 11 |
| Marlo Surgical Technology | 10 |
| Baxter Healthcare Corp | 9 |
Applicant names above are exactly as FDA published them, so one company can appear under several spellings.
Source: openFDA device/510k · retrieved
Watch HET
Get an email the morning anything changes in HET — 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.