Table And Attachments, Operating-Room
The Table and Attachments, Operating-Room is the surgical table and its associated positioning accessories used to support and position patients during operative procedures across a wide range of surgical specialties. It is classified as FDA Class 1, the lowest risk category, subject to general controls only with no premarket submission required. The product code is BWN, regulated under 21 CFR 878.4950 in the General and Plastic Surgery specialty.
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Basic Information
- Product Code
- BWN
- Device Class
- FDA class 1
- Regulation Number
- 878.4950
- Medical Specialty
- General, Plastic Surgery
- Review Panel
- SU
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 20 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K942699 | AIRFRAME SURGICAL DRAPE SUPPORT | Jul 13, 1994 | Substantially Equivalent | Alpha Surgical, Inc. |
| K935441 | INFINITECH BREATH EZ | Feb 07, 1994 | Substantially Equivalent | Infinitech, Inc. |
| K925005 | ISI SELF-SUPPORTING ARM | Apr 29, 1993 | Substantially Equivalent | Instrumentation Specialties, Inc. |
| K922288 | HOLDER, PEDIATRIC POSITION | Feb 10, 1993 | Substantially Equivalent | Yamashita and Hemsley Business Trust |
| K910783 | SHAMPAINE MODEL 3800 OR MURANAKA MODEL OR-604M | Apr 02, 1991 | Substantially Equivalent | Smith & Nephew Equipment Group |
| K902865 | BAUMER SURGICAL TABLE | Sep 10, 1990 | Substantially Equivalent | Sds Dental, Inc. |
| K884558 | IOP ADJUSTABLE STIRRUP | Nov 17, 1988 | Substantially Equivalent | Mend Technologies, Inc. |
| K875291 | SPINAL SURGERY FRAME | Jan 22, 1988 | Substantially Equivalent | T. Korossurgical Instruments Corp. |
| K873272 | ENDOSCOPY TABLE 1532 ENDOSTAR | Sep 08, 1987 | Substantially Equivalent | Stierlen-Maquet AG |
| K860177 | ALLEN UNIVERSAL STIRRUP | Feb 11, 1986 | Substantially Equivalent | Edgewater Medical Equipment Systems |
| K852332 | TABLE ACCESSORIES, OPERATING ROOM | Jul 02, 1985 | Substantially Equivalent | Scholten Surgical Instruments, Inc. |
| K843121 | GUIDE TO THE KNEE | Sep 07, 1984 | Substantially Equivalent | Dyonics, Inc. |
| K832340 | OPERATING ROOM TABLES HYDRAULIC | Aug 12, 1983 | Substantially Equivalent | Kamiya Tsusan Kaisha, Ltd. |
| K823772 | AMSCO ORTHOGRAPHIC 2 TABLE | Jan 14, 1983 | Substantially Equivalent | American Sterilizer Co. |
| K820574 | ARMBOARD FOR INTRAVENOUS ANES. IN DENTAL | Mar 23, 1982 | Substantially Equivalent | David Simmonds Co., Inc. |
| K812396 | ARTHRO-PREP REST | Nov 20, 1981 | Substantially Equivalent | Northwest Surgical Concepts, Inc. |
| K812395 | ARTHRO-PREP REST W/STAND | Nov 20, 1981 | Substantially Equivalent | Northwest Surgical Concepts, Inc. |
| K802271 | THE IMMOBILIZER FOR OPEN & ARTHROSCOPIC | Oct 23, 1980 | Substantially Equivalent | The Anspach Effort, Inc. |
| K792569 | OPERATING TABLES & AMPLINOX 03 | Jan 04, 1980 | Substantially Equivalent | Ets Rene Marzet |
| K791859 | TECNOL STIRRUPS STRAP | Oct 04, 1979 | Substantially Equivalent | Tecnol New Jersey Wound Care, Inc. |
FEI Numbers
This FDA classification entry is associated with 151 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 151 registration numbers. Click on an entry to view related FDA registrations.