FWZ — Operating Room Accessories Table Tray Class I
FDA product code FWZ covers "Operating Room Accessories Table Tray", 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
- FWZ
- Device Class
- Class I
- Regulation Number
- 878.4950
- Submission Type
- Review Panel
- SU
- Medical Specialty
- General, Plastic Surgery
- Implant
- No
Definition
This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K960019 | biopsys medical | RETRACTOR ARM CLAMP | February 9, 1996 |
| K945415 | d.l. nelson and assoc | 'LIL MAC ACCESSORY CLAMP(TM) | November 22, 1994 |
| K944779 | allen medical systems | CARBON LIGHTS HAND SURGERY TABLE | October 14, 1994 |
| K935381 | andronic devices | KAPS POSITIONING ARM | April 15, 1994 |
| K931037 | whitmore ent | WHITMORE VACUUM-LOCK SPINAL FRAME (VLSF-100) | July 30, 1993 |
| K926225 | american medical manufacturer | SPONGE COUNTER | March 5, 1993 |
| K925035 | d.l. nelson and assoc | MIDKIFF GEOSTATIC CLAMP | February 18, 1993 |
| K905565 | mcconnell orthopedic | LATERAL BUTTRESS SUPPORT | February 21, 1991 |
| K905564 | mcconnell orthopedic | PREP AND OPERATING STAND | February 21, 1991 |
| K910031 | orthopedic systems | PARK CITY SHOULDER POSITIONER | January 24, 1991 |
| K904826 | d.l. nelson and assoc | TKO TELESCOPING LITHOTOMY STIRRUP | October 31, 1990 |
| K897028 | lincoln mills | LINCOLN MILLS FOOT AND LEG HOLDER | January 12, 1990 |
| K893969 | gulftrade exim | DECUBITUS CARE PAD | July 14, 1989 |
| K890501 | 3m | SECOND ASSISTANT | February 10, 1989 |
| K885215 | lincoln mills | LINCOLN MILLS HIP HOLDER | January 13, 1989 |
| K884928 | faro medical technologies | FREE ARM(TM) | December 15, 1988 |
| K882078 | karlin technology | SPINAL SURGERY FRAME | June 16, 1988 |
| K880265 | orthopedic systems | WEHBE ARM HOLDER | February 18, 1988 |
| K873139 | leonard medical | VARUS AND VALGUS LEG HOLDER | September 16, 1987 |
| K873370 | edgewater medical equipment systems | ALLEN MALLEABLE ANESTHESIA SCREEN | September 11, 1987 |