FWZ — Operating Room Accessories Table Tray Class I
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 |