GDZ
16 FDA 510(k) clearances · Product code
21 daysmedian time to decision
56 days90th percentile
16clearances measured
FDA profile
- Official device name
- Handle, Scalpel
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4800
- Medical specialty
- General, Plastic Surgery
- Adverse events (MAUDE)
- 1992: 4 · 2000: 1 · 2007: 2 · 2008: 3 · 2017: 11 · 2026: 19
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| SPECTRA MEDICAL SAFETY SCAPEL (K091462) | Spectra, Inc. | 2009-12-15 |
| SCALPEL HANDLE (K890242) | Kinetic Medical Products | 1989-01-27 |
| BEAVER(R) HANDLE (K884512) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1988-11-17 |
| P.S.I.-DISPOSABLE SCALPEL SURGEONS HANDLE (K863951) | Precision Surgical Industries, Inc. | 1986-10-24 |
| THE S. CORDERO STYLUS (K863808) | S. Cordero Co. | 1986-10-14 |
| KEISEI HANDLES FOR SURGICAL BLADES (K863212) | Keisei Medical Industrial Co., Ltd. | 1986-09-02 |
| SCALPEL HANDLE (K854858) | Medelec Intl. Corp. | 1985-12-24 |
| SCALPEL HANDLE #7 SS 410 OR 420 (K852735) | The Huxley Instrument Corp. | 1985-07-15 |
| SCALPEL HANDLE #3 SS 410 OR 420 (K852711) | The Huxley Instrument Corp. | 1985-07-15 |
| 7-103, 7-104, 7-107 SCALPEL HANDLES, #3 #4 #7 (K851750) | Artiberia | 1985-06-20 |
| BRIMFIELD CANNULATED BLADE HOLDER (K852042) | Brimfield Scientific Instruments | 1985-06-11 |
| SURGICAL PAWS (K812876) | M-W Laboratories, Inc. | 1981-11-20 |
| ZEE SURGICAL INSTRUMENTS (K812814) | Zee Medical Products Co., Inc. | 1981-11-06 |
| BORES* ADJUSTABLE BLADE HOLDER (K812070) | Santa Barbara Medco, Inc. | 1981-08-18 |
| I.M. SCALPEL HANDLE (K810720) | Instrument Makar, Inc. | 1981-04-03 |
| SURGICAL BLADE HANDLES (K761035) | Parke-Davis Co. | 1976-12-21 |
Track GDZ automatically
Every clearance here is in the API, with alerts when new ones post.