FDA product code HIH: Hysteroscope (And Accessories)
HIH is the FDA product code for hysteroscope (and accessories). It is a Class II device, regulated under 21 CFR 884.1690 and reviewed by the Obstetrics and Gynecology panel. FDA has cleared 174 510(k) submissions under HIH, 21 in the last five years, from 91 different applicants. The average 510(k) review took 168 days (median 127); 148 days on average over the last three years. FDA has posted 16 recalls for HIH devices, 12 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Hysteroscope (And Accessories) |
| Device class | Class II |
| Regulation | 21 CFR 884.1690 |
| Review panel | OB — Obstetrics and Gynecology |
| Medical specialty | Obstetrics/Gynecology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for HIH
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 2 | 79 |
| 2018 | 8 | 152 |
| 2019 | 14 | 120 |
| 2020 | 7 | 176 |
| 2021 | 4 | 231 |
| 2022 | 2 | 167 |
| 2023 | 4 | 172 |
| 2024 | 6 | 157 |
| 2025 | 3 | 116 |
| 2026 | 6 | 172 |
Compare with all 510(k) review times · Search every HIH clearance
Top HIH applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Hologic, Inc. | 13 | 2019-08-29 |
| Smith & Nephew, Inc. | 10 | 2016-11-22 |
| KARL STORZ Endoscopy-America, Inc. | 9 | 2000-08-22 |
| Interlace Medical, Inc. | 6 | 2010-10-15 |
| Richard Wolf Medical Instruments Corp. | 6 | 2003-12-23 |
86 more applicants have HIH clearances. See the full list in Caduvo.
Most recent HIH clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K261102 | Karl Storz SE & CO. KG | UNIDRIVE Select System | 2026-09-18 | 168 |
| K254294 | Zhejiang Geyi Medical Instrument Co., Ltd. | Single-use Digital Hysteroscope (GYUT-A 12.6- 0, GYUT-A12.6- 12, GYUT-A 12.6- 22, GYUT-A 12.6- 30, GYUT-A 14.4- 0, GYUT-A 14.4- 12,GYUT-A 14.4- 22, GYUT-A 14.4- 30, GYUT-B 15- 0, GYUT-B 15- 12, GYUT-B 15-22, GYUT-B 15- 30) | 2026-09-08 | 251 |
| K260984 | Axora Medical, Inc. | HERizon RD5 Resecting Device (5FR1PK);HERizon RD5 Resecting Device - 5 pack (5FR5PK) | 2026-08-18 | 146 |
| K253020 | American Medical Endoscopy, Inc. | Strauss Surgical Resection Instruments | 2026-06-04 | 258 |
| K254050 | Suzhou AcuVu Medical Technology Co., Ltd. | Manual Tissue Removal Device | 2026-05-15 | 149 |
Recalls for HIH devices
16 product recalls in 13 recall events; 12 initiated in the last five years and 12 still open. Most recent: 2026-08-24.
| Year | Recalls |
|---|---|
| 2019 | 2 |
| 2020 | 1 |
| 2022 | 1 |
| 2023 | 4 |
| 2024 | 1 |
| 2025 | 3 |
| 2026 | 3 |
Frequently asked questions
What is FDA product code HIH?
HIH is the FDA product code for hysteroscope (and accessories). It is a Class II device, regulated under 21 CFR 884.1690 and reviewed by the Obstetrics and Gynecology panel.
What device class is HIH?
Class II, regulation 21 CFR 884.1690. Typical premarket route: 510(k).
How long does a 510(k) take for product code HIH?
Across 174 cleared submissions the average was 168 days from receipt to decision (median 127).
Which companies have the most HIH clearances?
Hologic, Inc. (13); Smith & Nephew, Inc. (10); KARL STORZ Endoscopy-America, Inc. (9); Interlace Medical, Inc. (6); Richard Wolf Medical Instruments Corp. (6).
Have HIH devices been recalled?
Yes: 16 product recalls across 13 recall events; the most recent began 2026-08-24.
Next steps
- Run an FDA pathway report with predicate devices for product code HIH
- Run a recall and safety report across every HIH manufacturer
- Watch product code HIH 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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