Spatula, Surgical, General & Plastic Surgery
The Spatula, Surgical, General and Plastic Surgery (product code GAF) is a flat-bladed hand instrument used to manipulate, separate, or spread tissue during general and plastic surgical procedures. It is classified as FDA Class 1, the lowest risk category, subject to general controls only 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.
Basic Information
- Product Code
- GAF
- 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 5 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K023688 | LEMAITRE VASCULAR DISPOSABLE VEIN STRIPPER | Jan 30, 2003 | Substantially Equivalent | LEMAITRE VASCULAR, INC. |
| K935357 | SNAP RECIPROCATING SAW | Jan 28, 1994 | Substantially Equivalent | SURGIQUIP, INC. |
| K890374 | ABDOMINAL SPATULA | Feb 03, 1989 | Substantially Equivalent | KINETIC MEDICAL PRODUCTS |
| K882793 | PMT FUKUSHIMA MICROSURGICAL INSTRUMENT LINE | Jul 18, 1988 | Substantially Equivalent | PMT CORP. |
| K822108 | CEMENT-PICK | Aug 11, 1982 | Substantially Equivalent | BIO-BLITZ, INC. |
FEI Numbers
This FDA classification entry is associated with 216 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 216 registration numbers. Click on an entry to view related FDA registrations.