BWN · Table And Attachments, Operating-Room
General, Plastic Surgery · 21 CFR 878.4950 · Class 1
Overview
| Product Code | BWN |
|---|---|
| Device Name | Table And Attachments, Operating-Room |
| 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.
Cleared Devices (20)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K942699 | AIRFRAME SURGICAL DRAPE SUPPORT | Alpha Surgical, Inc. | Jul 13, 1994 | SESE |
| K935441 | INFINITECH BREATH EZ | Infinitech, Inc. | Feb 7, 1994 | SESE |
| K925005 | ISI SELF-SUPPORTING ARM | Instrumentation Specialties, Inc. | Apr 29, 1993 | SESE |
| K922288 | HOLDER, PEDIATRIC POSITION | Yamashita and Hemsley Business Trust | Feb 10, 1993 | SESE |
| K910783 | SHAMPAINE MODEL 3800 OR MURANAKA MODEL OR-604M | Smith & Nephew Equipment Group | Apr 2, 1991 | SESE |
| K902865 | BAUMER SURGICAL TABLE | Sds Dental, Inc. | Sep 10, 1990 | SESE |
| K884558 | IOP ADJUSTABLE STIRRUP | Mend Technologies, Inc. | Nov 17, 1988 | SESE |
| K875291 | SPINAL SURGERY FRAME | T. Korossurgical Instruments Corp. | Jan 22, 1988 | SESE |
| K873272 | ENDOSCOPY TABLE 1532 ENDOSTAR | Stierlen-Maquet AG | Sep 8, 1987 | SESE |
| K860177 | ALLEN UNIVERSAL STIRRUP | Edgewater Medical Equipment Systems | Feb 11, 1986 | SESE |
| K852332 | TABLE ACCESSORIES, OPERATING ROOM | Scholten Surgical Instruments, Inc. | Jul 2, 1985 | SESE |
| K843121 | GUIDE TO THE KNEE | Dyonics, Inc. | Sep 7, 1984 | SESE |
| K832340 | OPERATING ROOM TABLES HYDRAULIC | Kamiya Tsusan Kaisha, Ltd. | Aug 12, 1983 | SESE |
| K823772 | AMSCO ORTHOGRAPHIC 2 TABLE | American Sterilizer Co. | Jan 14, 1983 | SESE |
| K820574 | ARMBOARD FOR INTRAVENOUS ANES. IN DENTAL | David Simmonds Co., Inc. | Mar 23, 1982 | SESE |
| K812396 | ARTHRO-PREP REST | Northwest Surgical Concepts, Inc. | Nov 20, 1981 | SESE |
| K812395 | ARTHRO-PREP REST W/STAND | Northwest Surgical Concepts, Inc. | Nov 20, 1981 | SESE |
| K802271 | THE IMMOBILIZER FOR OPEN & ARTHROSCOPIC | The Anspach Effort, Inc. | Oct 23, 1980 | SESE |
| K792569 | OPERATING TABLES & AMPLINOX 03 | Ets Rene Marzet | Jan 4, 1980 | SESE |
| K791859 | TECNOL STIRRUPS STRAP | Tecnol New Jersey Wound Care, Inc. | Oct 4, 1979 | SESE |
Top Applicants
- Northwest Surgical Concepts, Inc. — 2 clearances
- Yamashita and Hemsley Business Trust — 1 clearance
- The Anspach Effort, Inc. — 1 clearance
- Tecnol New Jersey Wound Care, Inc. — 1 clearance
- T. Korossurgical Instruments Corp. — 1 clearance
