FDA product code GDH: Gouge, Surgical, General & Plastic Surgery
GDH is the FDA product code for gouge, surgical, general & plastic surgery. It is a Class I device, regulated under 21 CFR 878.4800 and reviewed by the General and Plastic Surgery panel. FDA has cleared 6 510(k) submissions under GDH, from 4 different applicants. The average 510(k) review took 19 days (median 18).
Classification
| Field | Value |
|---|---|
| Device name | Gouge, Surgical, General & Plastic Surgery |
| Device class | Class I |
| Regulation | 21 CFR 878.4800 |
| Review panel | SU — General and Plastic Surgery |
| Medical specialty | General, Plastic Surgery |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every GDH clearance
Top GDH applicants
| Applicant | Clearances | Latest |
|---|---|---|
| United States Surgical, A Division of Tyco Healthc | 3 | 1990-08-09 |
| Zinnanti Surgical Instruments, Inc. | 1 | 1989-04-12 |
| Cher Mel Corp. | 1 | 1984-08-02 |
| V. Mueller O.V. Baxter Healthcare Corp. | 1 | 1976-11-03 |
Most recent GDH clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K903419 | United States Surgical, A Division of Tyco Healthc | MODIFIED SURGIPORT DISPOSABLE TROCAR AND SLEEVE | 1990-08-09 | 9 |
| K900487 | United States Surgical, A Division of Tyco Healthc | MODIFIED AUTO SUTURE SURGIPORT TROCAR & SLEEVE | 1990-02-09 | 17 |
| K891901 | Zinnanti Surgical Instruments, Inc. | GOUGES, ALEXANDER, BISHOP, LUCAS | 1989-04-12 | 19 |
| K874879 | United States Surgical, A Division of Tyco Healthc | AUTO SUTURE(R) SURGIPORT DISPOS SURG TROCAR/SLEEVE | 1987-12-17 | 38 |
| K842822 | Cher Mel Corp. | CHERMEL BONE GOUGES | 1984-08-02 | 14 |
Recalls for GDH devices
openFDA lists no recalls for product code GDH.
Frequently asked questions
What is FDA product code GDH?
GDH is the FDA product code for gouge, surgical, general & plastic surgery. It is a Class I device, regulated under 21 CFR 878.4800 and reviewed by the General and Plastic Surgery panel.
What device class is GDH?
Class I, regulation 21 CFR 878.4800. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code GDH?
Across 6 cleared submissions the average was 19 days from receipt to decision (median 18).
Which companies have the most GDH clearances?
United States Surgical, A Division of Tyco Healthc (3); Zinnanti Surgical Instruments, Inc. (1); Cher Mel Corp. (1); V. Mueller O.V. Baxter Healthcare Corp. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code GDH
- Run a recall and safety report across every GDH manufacturer
- Watch product code GDH 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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