FDA product code HGC: Clamp, Uterine
HGC is the FDA product code for clamp, uterine. It is a Class I device, regulated under 21 CFR 884.4520 and reviewed by the Obstetrics and Gynecology panel. FDA has cleared 2 510(k) submissions under HGC, from 2 different applicants. The average 510(k) review took 14 days (median 14). FDA has posted 11 recalls for HGC devices, 1 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Clamp, Uterine |
| Device class | Class I |
| Regulation | 21 CFR 884.4520 |
| Review panel | OB — Obstetrics and Gynecology |
| Medical specialty | Obstetrics/Gynecology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every HGC clearance
Top HGC applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Zinnanti Surgical Instruments, Inc. | 1 | 1989-03-29 |
| J. Sklar Mfg. Co., Inc. | 1 | 1977-07-27 |
Most recent HGC clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K891402 | Zinnanti Surgical Instruments, Inc. | UTERINE CLAMPS | 1989-03-29 | 15 |
| K771344 | J. Sklar Mfg. Co., Inc. | GUSBERG HYSTERECTOMY CLAMP | 1977-07-27 | 14 |
Recalls for HGC devices
11 product recalls in 2 recall events; 1 initiated in the last five years and 1 still open. Most recent: 2025-01-31.
| Year | Recalls |
|---|---|
| 2025 | 1 |
Frequently asked questions
What is FDA product code HGC?
HGC is the FDA product code for clamp, uterine. It is a Class I device, regulated under 21 CFR 884.4520 and reviewed by the Obstetrics and Gynecology panel.
What device class is HGC?
Class I, regulation 21 CFR 884.4520. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code HGC?
Across 2 cleared submissions the average was 14 days from receipt to decision (median 14).
Which companies have the most HGC clearances?
Zinnanti Surgical Instruments, Inc. (1); J. Sklar Mfg. Co., Inc. (1).
Have HGC devices been recalled?
Yes: 11 product recalls across 2 recall events; the most recent began 2025-01-31.
Next steps
- Run an FDA pathway report with predicate devices for product code HGC
- Run a recall and safety report across every HGC manufacturer
- Watch product code HGC 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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