GDH — Gouge, Surgical, General & Plastic Surgery Class I
FDA product code GDH covers "Gouge, Surgical, General & Plastic Surgery", a Class I medical device regulated under 21 CFR 878.4800. Submissions are reviewed by the General, Plastic Surgery panel. At least 6 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- GDH
- Device Class
- Class I
- Regulation Number
- 878.4800
- Submission Type
- Review Panel
- SU
- Medical Specialty
- General, Plastic Surgery
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K903419 | united states surgical, a division of tyco healthc | MODIFIED SURGIPORT DISPOSABLE TROCAR AND SLEEVE | August 9, 1990 |
| K900487 | united states surgical, a division of tyco healthc | MODIFIED AUTO SUTURE SURGIPORT TROCAR & SLEEVE | February 9, 1990 |
| K891901 | zinnanti surgical instruments | GOUGES, ALEXANDER, BISHOP, LUCAS | April 12, 1989 |
| K874879 | united states surgical, a division of tyco healthc | AUTO SUTURE(R) SURGIPORT DISPOS SURG TROCAR/SLEEVE | December 17, 1987 |
| K842822 | cher mel | CHERMEL BONE GOUGES | August 2, 1984 |
| K760850 | v. mueller o.v. baxter healthcare | PARKES HUMP GAUGE STRAIGHT 7 (18 CM) | November 3, 1976 |