Razor, Surgical
The Surgical Razor (product code LWK) is a disposable or reusable blade instrument used to shave or prepare the skin at the surgical site prior to a procedure, reducing the risk of infection from hair contamination. Regulated under 21 CFR 878.4800 and classified as a Class 1 device subject only to general controls, it falls under the General and Plastic Surgery specialty. It is not an implant, is not life-sustaining, and is not GMP-exempt.
Basic Information
- Product Code
- LWK
- 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 4 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K946162 | 3M(TM) SURGICAL SLIPPER, 9660 SERIES | Jan 24, 1995 | Substantially Equivalent | WAHL CLIPPER CORP. |
| K910524 | SURGICAL CLIPPER | Mar 28, 1991 | Substantially Equivalent | BAXTER HEALTHCARE CORP. |
| K874370 | SURGICAL PREP RAZOR | Nov 13, 1987 | Substantially Equivalent | DERMA-SAFE CO. |
| K874234 | SURGICAL PREP RAZOR, STRAIGHT TYPE | Nov 02, 1987 | Substantially Equivalent | DERMA-SAFE CO. |
FEI Numbers
This FDA classification entry is associated with 122 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 122 registration numbers. Click on an entry to view related FDA registrations.