FWZ · Operating Room Accessories Table Tray
General, Plastic Surgery · 21 CFR 878.4950 · Class 1
Overview
| Product Code | FWZ |
|---|---|
| Device Name | Operating Room Accessories Table Tray |
| Regulation | 21 CFR 878.4950 |
| Device Class | Class 1 |
| Review Panel | General, Plastic Surgery |
Identification
A manual operating table and accessories and a manual operating chair and accessories are nonpowered devices, usually with movable components, intended to be used to support a patient during diagnostic examinations or surgical procedures.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.
Recent Cleared Devices (20 of 61)
Showing 20 most recent of 61 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K960019 | RETRACTOR ARM CLAMP | Biopsys Medical, Inc. | Feb 9, 1996 | SESE |
| K945415 | 'LIL MAC ACCESSORY CLAMP(TM) | D.L. Nelson and Assoc., Inc. | Nov 22, 1994 | SESE |
| K944779 | CARBON LIGHTS HAND SURGERY TABLE | Allen Medical Systems, Inc. | Oct 14, 1994 | SESE |
| K935381 | KAPS POSITIONING ARM | Andronic Devices, Ltd. | Apr 15, 1994 | SESE |
| K931037 | WHITMORE VACUUM-LOCK SPINAL FRAME (VLSF-100) | Whitmore Ent., Inc. | Jul 30, 1993 | SESE |
| K926225 | SPONGE COUNTER | American Medical Manufacturer, Inc. | Mar 5, 1993 | SESE |
| K925035 | MIDKIFF GEOSTATIC CLAMP | D.L. Nelson and Assoc., Inc. | Feb 18, 1993 | SESE |
| K905565 | LATERAL BUTTRESS SUPPORT | Mcconnell Orthopedic | Feb 21, 1991 | SESE |
| K905564 | PREP AND OPERATING STAND | Mcconnell Orthopedic | Feb 21, 1991 | SESE |
| K910031 | PARK CITY SHOULDER POSITIONER | Orthopedic Systems, Inc. | Jan 24, 1991 | SESE |
| K904826 | TKO TELESCOPING LITHOTOMY STIRRUP | D.L. Nelson and Assoc., Inc. | Oct 31, 1990 | SESE |
| K897028 | LINCOLN MILLS FOOT AND LEG HOLDER | Lincoln Mills, Inc. | Jan 12, 1990 | SESE |
| K893969 | DECUBITUS CARE PAD | Gulftrade Exim, Inc. | Jul 14, 1989 | SESE |
| K890501 | SECOND ASSISTANT | 3M Company | Feb 10, 1989 | SESE |
| K885215 | LINCOLN MILLS HIP HOLDER | Lincoln Mills, Inc. | Jan 13, 1989 | SESE |
| K884928 | FREE ARM(TM) | Faro Medical Technologies, Inc. | Dec 15, 1988 | SESE |
| K882078 | SPINAL SURGERY FRAME | Karlin Technology, Inc. | Jun 16, 1988 | SESE |
| K880265 | WEHBE ARM HOLDER | Orthopedic Systems, Inc. | Feb 18, 1988 | SESE |
| K873139 | VARUS AND VALGUS LEG HOLDER | Leonard Medical, Inc. | Sep 16, 1987 | SESE |
| K873370 | ALLEN MALLEABLE ANESTHESIA SCREEN | Edgewater Medical Equipment Systems | Sep 11, 1987 | SESE |
Top Applicants
- Mcconnell Orthopedic — 14 clearances
- Orthopedic Systems, Inc. — 8 clearances
- D.L. Nelson and Assoc., Inc. — 3 clearances
- The Anspach Effort, Inc. — 2 clearances
- Lincoln Mills, Inc. — 2 clearances
