BWN — Table And Attachments, Operating-Room Class I
FDA product code BWN covers "Table And Attachments, Operating-Room", a Class I medical device regulated under 21 CFR 878.4950. 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
- BWN
- Device Class
- Class I
- Regulation Number
- 878.4950
- Submission Type
- Review Panel
- SU
- Medical Specialty
- General, Plastic Surgery
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K942699 | alpha surgical | AIRFRAME SURGICAL DRAPE SUPPORT | July 13, 1994 |
| K935441 | infinitech | INFINITECH BREATH EZ | February 7, 1994 |
| K925005 | instrumentation specialties | ISI SELF-SUPPORTING ARM | April 29, 1993 |
| K922288 | yamashita and hemsley business trust | HOLDER, PEDIATRIC POSITION | February 10, 1993 |
| K910783 | smith and nephew equipment group | SHAMPAINE MODEL 3800 OR MURANAKA MODEL OR-604M | April 2, 1991 |
| K902865 | sds dental | BAUMER SURGICAL TABLE | September 10, 1990 |
| K884558 | mend technologies | IOP ADJUSTABLE STIRRUP | November 17, 1988 |
| K875291 | t. korossurgical instruments | SPINAL SURGERY FRAME | January 22, 1988 |
| K873272 | stierlen-maquet | ENDOSCOPY TABLE 1532 ENDOSTAR | September 8, 1987 |
| K860177 | edgewater medical equipment systems | ALLEN UNIVERSAL STIRRUP | February 11, 1986 |
| K852332 | scholten surgical instruments | TABLE ACCESSORIES, OPERATING ROOM | July 2, 1985 |
| K843121 | dyonics | GUIDE TO THE KNEE | September 7, 1984 |
| K832340 | kamiya tsusan kaisha | OPERATING ROOM TABLES HYDRAULIC | August 12, 1983 |
| K823772 | american sterilizer | AMSCO ORTHOGRAPHIC 2 TABLE | January 14, 1983 |
| K820574 | david simmonds co | ARMBOARD FOR INTRAVENOUS ANES. IN DENTAL | March 23, 1982 |
| K812395 | northwest surgical concepts | ARTHRO-PREP REST W/STAND | November 20, 1981 |
| K812396 | northwest surgical concepts | ARTHRO-PREP REST | November 20, 1981 |
| K802271 | anspach effort | THE IMMOBILIZER FOR OPEN & ARTHROSCOPIC | October 23, 1980 |
| K792569 | ets rene marzet | OPERATING TABLES & AMPLINOX 03 | January 4, 1980 |
| K791859 | tecnol new jersey wound care | TECNOL STIRRUPS STRAP | October 4, 1979 |