FDA product code HET: Laparoscope, Gynecologic (And Accessories)
HET is the FDA product code for laparoscope, gynecologic (and accessories). It is a Class II device, regulated under 21 CFR 884.1720 and reviewed by the Obstetrics and Gynecology panel. FDA has cleared 338 510(k) submissions under HET, 3 in the last five years, from 145 different applicants. The average 510(k) review took 205 days (median 150); 144 days on average over the last three years. FDA has posted 19 recalls for HET devices, 6 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Laparoscope, Gynecologic (And Accessories) |
| Device class | Class II |
| Regulation | 21 CFR 884.1720 |
| Review panel | OB — Obstetrics and Gynecology |
| Medical specialty | Obstetrics/Gynecology |
| Premarket route | 510(k) |
510(k) clearances per year for HET
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 2 | 89 |
| 2018 | 1 | 125 |
| 2019 | 2 | 216 |
| 2020 | 2 | 115 |
| 2021 | 4 | 288 |
| 2022 | 1 | 189 |
| 2025 | 2 | 144 |
Top HET applicants
| Applicant | Clearances | Latest |
|---|---|---|
| KARL STORZ Endoscopy-America, Inc. | 29 | 2015-11-20 |
| Dixon Medical, Inc. | 12 | 1990-10-17 |
| ETHICON, Inc. | 11 | 2013-09-27 |
| Marlo Surgical Technology | 10 | 1996-10-21 |
| Richard Wolf Medical Instruments Corp. | 9 | 2004-07-09 |
140 more applicants have HET clearances. See the full list in Caduvo.
Most recent HET clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K250939 | Precision Robotics (Hong Kong) Limited | SIRIUS Endoscope System (PR-SI-1230) | 2025-08-29 | 154 |
| K243821 | A.M.I. Agency For Medical Innovations GmbH | i-Cut | 2025-04-25 | 134 |
| K221642 | Precision Robotics (Hong Kong) Limited | SIRIUS Endoscope System | 2022-12-12 | 189 |
| K210116 | Surgnova Healthcare Technologies (Zhejiang) Co., Ltd. | Video Endoscopy System, 3D Video Endoscopy System | 2021-10-13 | 267 |
| K201832 | Olympus Medical Systems Corp. | Endoeye Flex Deflectable Videoscope Olympus LTF-S190-5 | 2021-09-17 | 442 |
Recalls for HET devices
19 product recalls in 13 recall events; 6 initiated in the last five years and 5 still open. Most recent: 2024-02-27.
| Year | Recalls |
|---|---|
| 2017 | 1 |
| 2022 | 1 |
| 2023 | 4 |
| 2024 | 1 |
Frequently asked questions
What is FDA product code HET?
HET is the FDA product code for laparoscope, gynecologic (and accessories). It is a Class II device, regulated under 21 CFR 884.1720 and reviewed by the Obstetrics and Gynecology panel.
What device class is HET?
Class II, regulation 21 CFR 884.1720. Typical premarket route: 510(k).
How long does a 510(k) take for product code HET?
Across 338 cleared submissions the average was 205 days from receipt to decision (median 150).
Which companies have the most HET clearances?
KARL STORZ Endoscopy-America, Inc. (29); Dixon Medical, Inc. (12); ETHICON, Inc. (11); Marlo Surgical Technology (10); Richard Wolf Medical Instruments Corp. (9).
Have HET devices been recalled?
Yes: 19 product recalls across 13 recall events; the most recent began 2024-02-27.
Next steps
- Run an FDA pathway report with predicate devices for product code HET
- Run a recall and safety report across every HET manufacturer
- Watch product code HET for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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