FDA product code HDC: Tenaculum, Uterine
HDC is the FDA product code for tenaculum, uterine. It is a Class II device, regulated under 21 CFR 884.4530 and reviewed by the Obstetrics and Gynecology panel. FDA has cleared 20 510(k) submissions under HDC, 1 in the last five years, from 15 different applicants. The average 510(k) review took 87 days (median 42). FDA has posted 8 recalls for HDC devices.
Classification
| Field | Value |
|---|---|
| Device name | Tenaculum, Uterine |
| Device class | Class II |
| Regulation | 21 CFR 884.4530 |
| 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 HDC
| Year | Clearances | Avg. review days |
|---|---|---|
| 2021 | 1 | 231 |
| 2023 | 1 | 33 |
Compare with all 510(k) review times · Search every HDC clearance
Top HDC applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Simpson/Basye, Inc. | 3 | 1989-03-29 |
| Aspivix SA | 2 | 2023-01-25 |
| Vascular Control Systems, Inc. | 2 | 2006-04-21 |
| Ron-Tech Medical , Ltd. | 2 | 2004-01-09 |
| Bioceptive, Inc. | 1 | 2014-12-19 |
10 more applicants have HDC clearances. See the full list in Caduvo.
Most recent HDC clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K223866 | Aspivix SA | Carevix Suction Cervical Stabilizer | 2023-01-25 | 33 |
| K203820 | Aspivix SA | ASPIVIX v1.1 Cervical Suction Tenaculum | 2021-08-17 | 231 |
| K142204 | Bioceptive, Inc. | Bioceptive Suction Cervical Retractor | 2014-12-19 | 130 |
| K082349 | J. Jamner Surgical Instruments, Inc. | JARIT HULKA UTERINE TENACULUM FORCEPS | 2008-11-21 | 98 |
| K073182 | Gyn-Disposables, Inc. | GYN DISPOSABLES TENACULUM 356T | 2007-11-28 | 15 |
Recalls for HDC devices
8 product recalls in 3 recall events; 0 initiated in the last five years and 6 still open. Most recent: 2021-09-10.
| Year | Recalls |
|---|---|
| 2021 | 6 |
Frequently asked questions
What is FDA product code HDC?
HDC is the FDA product code for tenaculum, uterine. It is a Class II device, regulated under 21 CFR 884.4530 and reviewed by the Obstetrics and Gynecology panel.
What device class is HDC?
Class II, regulation 21 CFR 884.4530. Typical premarket route: 510(k).
How long does a 510(k) take for product code HDC?
Across 20 cleared submissions the average was 87 days from receipt to decision (median 42).
Which companies have the most HDC clearances?
Simpson/Basye, Inc. (3); Aspivix SA (2); Vascular Control Systems, Inc. (2); Ron-Tech Medical , Ltd. (2); Bioceptive, Inc. (1).
Have HDC devices been recalled?
Yes: 8 product recalls across 3 recall events; the most recent began 2021-09-10.
Next steps
- Run an FDA pathway report with predicate devices for product code HDC
- Run a recall and safety report across every HDC manufacturer
- Watch product code HDC 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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