GDZ — Handle, Scalpel Class I
FDA product code GDZ covers "Handle, Scalpel", a Class I medical device regulated under 21 CFR 878.4800. Submissions are reviewed by the General, Plastic Surgery panel. At least 16 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- GDZ
- 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 |
|---|---|---|---|
| K091462 | spectra | SPECTRA MEDICAL SAFETY SCAPEL | December 15, 2009 |
| K890242 | kinetic medical products | SCALPEL HANDLE | January 27, 1989 |
| K884512 | bd becton dickinson vacutainer systems preanalytic | BEAVER(R) HANDLE | November 17, 1988 |
| K863951 | precision surgical industries | P.S.I.-DISPOSABLE SCALPEL SURGEONS HANDLE | October 24, 1986 |
| K863808 | s. cordero | THE S. CORDERO STYLUS | October 14, 1986 |
| K863212 | keisei medical industrial co | KEISEI HANDLES FOR SURGICAL BLADES | September 2, 1986 |
| K854858 | medelec intl | SCALPEL HANDLE | December 24, 1985 |
| K852735 | huxley instrument | SCALPEL HANDLE #7 SS 410 OR 420 | July 15, 1985 |
| K852711 | huxley instrument | SCALPEL HANDLE #3 SS 410 OR 420 | July 15, 1985 |
| K851750 | artiberia | 7-103, 7-104, 7-107 SCALPEL HANDLES, #3 #4 #7 | June 20, 1985 |
| K852042 | brimfield scientific instruments | BRIMFIELD CANNULATED BLADE HOLDER | June 11, 1985 |
| K812876 | m-w laboratories | SURGICAL PAWS | November 20, 1981 |
| K812814 | zee medical products co | ZEE SURGICAL INSTRUMENTS | November 6, 1981 |
| K812070 | santa barbara medco | BORES* ADJUSTABLE BLADE HOLDER | August 18, 1981 |
| K810720 | instrument makar | I.M. SCALPEL HANDLE | April 3, 1981 |
| K761035 | parke-davis | SURGICAL BLADE HANDLES | December 21, 1976 |