Product code GDZ— General, Plastic Surgery
SCALPEL HANDLE
- Classification name
- Handle, Scalpel
- Device class
- Class 1
- Regulation
- 21 CFR 878.4800
- Advisory panel
- General, Plastic Surgery
- Total cleared
- 16
- First cleared
- Most recent
Market context for product code GDZ
FDA has cleared devices under product code GDZ between 1976 and 2009, filed by 15 applicant companies. No FDA device recalls reference this product code. Class I devices are low-risk and subject to FDA general controls; many Class I device types are exempt from 510(k) premarket notification.
Clearances per year
- 2009
- 1989
- 1988
- 1986
- 1985
- 1981
- 1976
Top applicants under product code GDZ
Adverse events under product code GDZ
product code GDZ- Other
- 1
- Total
- 1
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recent clearances under product code GDZ
- K091462 — SPECTRA MEDICAL SAFETY SCAPEL
- K890242 — SCALPEL HANDLE
- K884512 — BEAVER(R) HANDLE
- K863951 — P.S.I.-DISPOSABLE SCALPEL SURGEONS HANDLE
- K863808 — THE S. CORDERO STYLUS
- K863212 — KEISEI HANDLES FOR SURGICAL BLADES
- K854858 — SCALPEL HANDLE
- K852711 — SCALPEL HANDLE #3 SS 410 OR 420
- K852735 — SCALPEL HANDLE #7 SS 410 OR 420
- K851750 — 7-103, 7-104, 7-107 SCALPEL HANDLES, #3 #4 #7
- K852042 — BRIMFIELD CANNULATED BLADE HOLDER
- K812876 — SURGICAL PAWS
- K812814 — ZEE SURGICAL INSTRUMENTS
- K812070 — BORES* ADJUSTABLE BLADE HOLDER
- K810720 — I.M. SCALPEL HANDLE
- K761035 — SURGICAL BLADE HANDLES
Data sourced from openFDA. This site is unofficial and independent of the FDA.