FDA product code HEX: Colposcope (And Colpomicroscope)
HEX is the FDA product code for colposcope (and colpomicroscope). It is a Class II device, regulated under 21 CFR 884.1630 and reviewed by the Obstetrics and Gynecology panel. FDA has cleared 56 510(k) submissions under HEX, 1 in the last five years, from 43 different applicants. The average 510(k) review took 153 days (median 102); 263 days on average over the last three years.
Classification
| Field | Value |
|---|---|
| Device name | Colposcope (And Colpomicroscope) |
| Device class | Class II |
| Regulation | 21 CFR 884.1630 |
| 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 HEX
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 1 | 96 |
| 2018 | 2 | 108 |
| 2019 | 1 | 96 |
| 2024 | 1 | 263 |
Compare with all 510(k) review times · Search every HEX clearance
Top HEX applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Wallach Surgical Devices, Inc. | 4 | 1987-08-05 |
| Lutech Industries, Inc. | 3 | 2017-05-21 |
| Dynatech Cryomedical Co. | 3 | 1977-06-03 |
| CooperSurgical, Inc. | 2 | 2014-10-23 |
| Medgyn Products, Inc. | 2 | 2013-06-12 |
38 more applicants have HEX clearances. See the full list in Caduvo.
Most recent HEX clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K233043 | Periwinkle Technologies Pvt., Ltd. | Smart Scope® CX | 2024-06-14 | 263 |
| K190187 | Illumigyn , Ltd. | Gynescope System | 2019-05-08 | 96 |
| K182764 | Biop Medical , Ltd. | Biop Digital Colposcope | 2018-11-27 | 60 |
| K181034 | Hadleigh Health Technologies, LLC | Pocket Colposcope System | 2018-09-21 | 156 |
| K170446 | Lutech Industries, Inc. | LT-300 SD Digital Video Colposcope | 2017-05-21 | 96 |
Recalls for HEX devices
openFDA lists no recalls for product code HEX.
Frequently asked questions
What is FDA product code HEX?
HEX is the FDA product code for colposcope (and colpomicroscope). It is a Class II device, regulated under 21 CFR 884.1630 and reviewed by the Obstetrics and Gynecology panel.
What device class is HEX?
Class II, regulation 21 CFR 884.1630. Typical premarket route: 510(k).
How long does a 510(k) take for product code HEX?
Across 56 cleared submissions the average was 153 days from receipt to decision (median 102).
Which companies have the most HEX clearances?
Wallach Surgical Devices, Inc. (4); Lutech Industries, Inc. (3); Dynatech Cryomedical Co. (3); CooperSurgical, Inc. (2); Medgyn Products, Inc. (2).
Next steps
- Run an FDA pathway report with predicate devices for product code HEX
- Run a recall and safety report across every HEX manufacturer
- Watch product code HEX 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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