Handle, Scalpel
The Handle, Scalpel (product code GDZ) is the reusable handle component of a two-piece scalpel system, designed to securely grip interchangeable scalpel blades for use in making surgical incisions during general or plastic surgery procedures. It is classified as FDA Class 1, the lowest risk level, subject only to general controls and not requiring premarket notification. The device is regulated under 21 CFR 878.4800 in the General, Plastic Surgery specialty (SU). No special flags apply to this device.
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Basic Information
- Product Code
- GDZ
- Device Class
- FDA class 1
- Regulation Number
- 878.4800
- Medical Specialty
- General, Plastic Surgery
- Review Panel
- SU
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 16 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K091462 | SPECTRA MEDICAL SAFETY SCAPEL | Dec 15, 2009 | Substantially Equivalent | Spectra, Inc. |
| K890242 | SCALPEL HANDLE | Jan 27, 1989 | Substantially Equivalent | Kinetic Medical Products |
| K884512 | BEAVER(R) HANDLE | Nov 17, 1988 | Substantially Equivalent | Bd Becton Dickinson Vacutainer Systems Preanalytic |
| K863951 | P.S.I.-DISPOSABLE SCALPEL SURGEONS HANDLE | Oct 24, 1986 | Substantially Equivalent | Precision Surgical Industries, Inc. |
| K863808 | THE S. CORDERO STYLUS | Oct 14, 1986 | Substantially Equivalent | S. Cordero Co. |
| K863212 | KEISEI HANDLES FOR SURGICAL BLADES | Sep 02, 1986 | Substantially Equivalent | Keisei Medical Industrial Co., Ltd. |
| K854858 | SCALPEL HANDLE | Dec 24, 1985 | Substantially Equivalent | Medelec Intl. Corp. |
| K852735 | SCALPEL HANDLE #7 SS 410 OR 420 | Jul 15, 1985 | Substantially Equivalent | The Huxley Instrument Corp. |
| K852711 | SCALPEL HANDLE #3 SS 410 OR 420 | Jul 15, 1985 | Substantially Equivalent | The Huxley Instrument Corp. |
| K851750 | 7-103, 7-104, 7-107 SCALPEL HANDLES, #3 #4 #7 | Jun 20, 1985 | Substantially Equivalent | Artiberia |
| K852042 | BRIMFIELD CANNULATED BLADE HOLDER | Jun 11, 1985 | Substantially Equivalent | Brimfield Scientific Instruments |
| K812876 | SURGICAL PAWS | Nov 20, 1981 | Substantially Equivalent | M-W Laboratories, Inc. |
| K812814 | ZEE SURGICAL INSTRUMENTS | Nov 06, 1981 | Substantially Equivalent | Zee Medical Products Co., Inc. |
| K812070 | BORES* ADJUSTABLE BLADE HOLDER | Aug 18, 1981 | Substantially Equivalent | Santa Barbara Medco, Inc. |
| K810720 | I.M. SCALPEL HANDLE | Apr 03, 1981 | Substantially Equivalent | Instrument Makar, Inc. |
| K761035 | SURGICAL BLADE HANDLES | Dec 21, 1976 | Substantially Equivalent | Parke-Davis Co. |
FEI Numbers
This FDA classification entry is associated with 430 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 430 registration numbers. Click on an entry to view related FDA registrations.