FDA product code HIC: Speculum, Vaginal, Nonmetal, Fiberoptic
HIC is the FDA product code for speculum, vaginal, nonmetal, fiberoptic. It is a Class II device, regulated under 21 CFR 884.4530 and reviewed by the Obstetrics and Gynecology panel. FDA has cleared 5 510(k) submissions under HIC, from 5 different applicants. The average 510(k) review took 227 days (median 90).
Classification
| Field | Value |
|---|---|
| Device name | Speculum, Vaginal, Nonmetal, Fiberoptic |
| Device class | Class II |
| Regulation | 21 CFR 884.4530 |
| Review panel | OB — Obstetrics and Gynecology |
| Medical specialty | Obstetrics/Gynecology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every HIC clearance
Top HIC applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Trylon Corp. | 1 | 1996-03-21 |
| Galenica Enterprises, Inc. | 1 | 1994-09-08 |
| Sims Surgical, Inc. | 1 | 1990-07-03 |
| Tri-State Hospital Supply Corp. | 1 | 1990-03-16 |
| Trylon Associates, Ltd. | 1 | 1985-12-27 |
Most recent HIC clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K955790 | Trylon Corp. | PAP PLUS SPECULOSCOPY COMPREHENSIVE PELVIC EXAM TRAY | 1996-03-21 | 90 |
| K923656 | Galenica Enterprises, Inc. | LIGHTING SOURCE SYSTEM | 1994-09-08 | 787 |
| K902516 | Sims Surgical, Inc. | NEW LENGTH SUGITA APPLIERS | 1990-07-03 | 26 |
| K897100 | Tri-State Hospital Supply Corp. | CENTURION VAGINAL SPECULUM | 1990-03-16 | 85 |
| K853257 | Trylon Associates, Ltd. | SPECULITE DISPOSABLE VAGINAL LIGHT | 1985-12-27 | 147 |
Recalls for HIC devices
openFDA lists no recalls for product code HIC.
Frequently asked questions
What is FDA product code HIC?
HIC is the FDA product code for speculum, vaginal, nonmetal, fiberoptic. It is a Class II device, regulated under 21 CFR 884.4530 and reviewed by the Obstetrics and Gynecology panel.
What device class is HIC?
Class II, regulation 21 CFR 884.4530. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code HIC?
Across 5 cleared submissions the average was 227 days from receipt to decision (median 90).
Which companies have the most HIC clearances?
Trylon Corp. (1); Galenica Enterprises, Inc. (1); Sims Surgical, Inc. (1); Tri-State Hospital Supply Corp. (1); Trylon Associates, Ltd. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code HIC
- Run a recall and safety report across every HIC manufacturer
- Watch product code HIC 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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