FXP — Cover, Shoe, Operating-Room Class I
FDA product code FXP covers "Cover, Shoe, Operating-Room", a Class I medical device regulated under 21 CFR 878.4040. Submissions are reviewed by the General, Plastic Surgery panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- FXP
- Device Class
- Class I
- Regulation Number
- 878.4040
- Submission Type
- Review Panel
- HO
- Medical Specialty
- General, Plastic Surgery
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K971076 | primeline medical products | PRIMED SHOE COVERS, PRIMED HEAD COVERS | January 13, 1998 |
| K971191 | far east science and technology development co | FAR-EAST SHOE COVERS | July 10, 1997 |
| K970815 | allegiance healthcare | CONVERTORS IMPERVIOUS SHOE COVERS | March 27, 1997 |
| K961342 | copioumed intl | SHOE COVER, NON-STERILE | December 30, 1996 |
| K955835 | instrument makar | FLUID BARRIER BOOT KNEE & ANKLE-HIGH | November 19, 1996 |
| K952937 | amerasia | NIOMED NON-SKID SHOE COVERS | October 23, 1995 |
| K952897 | amerasia | NIOMED SHOE COVERS | October 23, 1995 |
| K943034 | thantex specialties | OREX SHOE COVERS | January 2, 1995 |
| K932738 | kappler | KAPPLER PRO/VENT BOOT | March 29, 1994 |
| K925815 | amsco sterile recoveries | REUSABLE LIQUIDPROOF BOOTIE | July 9, 1993 |
| K914702 | depuy | STERILE VIEW(TM) KNEE-HIGH BOOTS/DEPUY SHOE BOOTS | January 29, 1993 |
| K913628 | gem nonwovews | DISPOSABLE SHOE COVER | October 4, 1991 |
| K894383 | american threshold industries | DISPOSABLE SHOE COVER | September 12, 1989 |
| K893702 | tecnol new jersey wound care | TECNOL GAITERS PRODUCT NUMBER 47725-010 | June 23, 1989 |
| K883657 | james river | SKID RESISTANT, LONG LASTING SHOE COVERS | September 15, 1988 |
| K882280 | a plus international | COVER, SHOE OPERATING ROOM | June 23, 1988 |
| K882128 | tecnol new jersey wound care | TECNOL TIGER PAWS PRODUCT NUMBER 47705-010 | June 15, 1988 |
| K880093 | james river | CARETEX SKID RESISTANT SHOE COVERS | January 29, 1988 |
| K874064 | interpro intl | SHOE COVERS | November 4, 1987 |
| K872797 | abco dealers | NON-SKID SHOE COVERS | August 4, 1987 |