GEF — Applier, Staple, Surgical, Class I
FDA product code GEF covers "Applier, Staple, Surgical,", a Class I medical device regulated under 21 CFR 878.4800. Submissions are reviewed by the General, Plastic Surgery panel. At least 4 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- GEF
- 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 |
|---|---|---|---|
| K933508 | richard-allan medical | REFLEX SDD SURGICAL STAPLER | November 23, 1993 |
| K915670 | microaire | MICROAIRE MODEL 2600 | March 18, 1992 |
| K854568 | american v. mueller | V. MUELLER PNEUMO-INTESTINAL 15 VASCULAR & 30 STAP | December 2, 1985 |
| K823888 | 3m | 3M FRASCIA STAPLING SYSTEM | January 9, 1983 |