Product code BWN
- Device name
- Table And Attachments, Operating-Room
- Medical specialty
- General, Plastic Surgery
- Device class
- 1
- Regulation number
- 878.4950
- Review panel
- SU
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K942699 | AIRFRAME SURGICAL DRAPE SUPPORT | Alpha Surgical, Inc. | 1994-07-13 |
| K935441 | INFINITECH BREATH EZ | Infinitech, Inc. | 1994-02-07 |
| K925005 | ISI SELF-SUPPORTING ARM | Instrumentation Specialties, Inc. | 1993-04-29 |
| K922288 | HOLDER, PEDIATRIC POSITION | Yamashita and Hemsley Business Trust | 1993-02-10 |
| K910783 | SHAMPAINE MODEL 3800 OR MURANAKA MODEL OR-604M | Smith & Nephew Equipment Group | 1991-04-02 |
| K902865 | BAUMER SURGICAL TABLE | Sds Dental, Inc. | 1990-09-10 |
| K884558 | IOP ADJUSTABLE STIRRUP | Mend Technologies, Inc. | 1988-11-17 |
| K875291 | SPINAL SURGERY FRAME | T. Korossurgical Instruments Corp. | 1988-01-22 |
| K873272 | ENDOSCOPY TABLE 1532 ENDOSTAR | Stierlen-Maquet AG | 1987-09-08 |
| K860177 | ALLEN UNIVERSAL STIRRUP | Edgewater Medical Equipment Systems | 1986-02-11 |
| K852332 | TABLE ACCESSORIES, OPERATING ROOM | Scholten Surgical Instruments, Inc. | 1985-07-02 |
| K843121 | GUIDE TO THE KNEE | Dyonics, Inc. | 1984-09-07 |
| K832340 | OPERATING ROOM TABLES HYDRAULIC | Kamiya Tsusan Kaisha, Ltd. | 1983-08-12 |
| K823772 | AMSCO ORTHOGRAPHIC 2 TABLE | American Sterilizer Co. | 1983-01-14 |
| K820574 | ARMBOARD FOR INTRAVENOUS ANES. IN DENTAL | David Simmonds Co., Inc. | 1982-03-23 |
| K812395 | ARTHRO-PREP REST W/STAND | Northwest Surgical Concepts, Inc. | 1981-11-20 |
| K812396 | ARTHRO-PREP REST | Northwest Surgical Concepts, Inc. | 1981-11-20 |
| K802271 | THE IMMOBILIZER FOR OPEN & ARTHROSCOPIC | The Anspach Effort, Inc. | 1980-10-23 |
| K792569 | OPERATING TABLES & AMPLINOX 03 | Ets Rene Marzet | 1980-01-04 |
| K791859 | TECNOL STIRRUPS STRAP | Tecnol New Jersey Wound Care, Inc. | 1979-10-04 |
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|---|---|---|---|
| 00724995363321 | NA | STERIS CORPORATION | 2026-10-08 |
| 00724995363338 | NA | STERIS CORPORATION | 2026-10-08 |
| 00724995363345 | NA | STERIS CORPORATION | 2026-10-08 |
| 00724995363352 | NA | STERIS CORPORATION | 2026-10-08 |
| 00724995363888 | NA | STERIS CORPORATION | 2026-10-08 |
| 00724995363895 | NA | STERIS CORPORATION | 2026-10-08 |
| 00842102116506 | StrongArm Surgical Holders and Positioners | FLEXBAR MACHINE CORPORATION | 2026-10-07 |
| 00815849025615 | Custom Medical Specialties, Inc. | CUSTOM ASSEMBLIES, INC. | 2026-10-06 |
| 00851674008683 | SmartSurface Riser - Stryker D860 | Elucent Medical, Inc. | 2026-09-28 |
| 00842102116469 | Flexarm Surgical Holders and Positioners | FLEXBAR MACHINE CORPORATION | 2026-08-03 |
| 00842180148864 | ELMED INCORPORATED | ELMED INCORPORATED | 2026-06-08 |
| 00724995229238 | NA | STERIS CORPORATION | 2024-03-08 |
| 00724995220228 | NA | STERIS CORPORATION | 2024-01-31 |
| 00724995225117 | NA | STERIS CORPORATION | 2023-10-03 |
| 10810087352551 | Coulmed | Coulmed Products Group LLC | 2023-01-06 |
| 10810087352506 | Coulmed | Coulmed Products Group LLC | 2023-01-06 |
| 10810087352513 | Coulmed | Coulmed Products Group LLC | 2023-01-06 |
| 10810087352520 | Coulmed | Coulmed Products Group LLC | 2023-01-06 |
| 10810087352537 | Coulmed | Coulmed Products Group LLC | 2023-01-06 |
| 10810087352544 | Coulmed | Coulmed Products Group LLC | 2023-01-06 |
| 10190676001122 | POSEY | POSEY PRODUCTS, LLC | 2022-10-05 |
| 00724995156978 | NA | STERIS CORPORATION | 2021-04-02 |
| 10724995191327 | NA | STERIS CORPORATION | 2021-04-02 |
| 10724995191273 | NA | STERIS CORPORATION | 2021-04-02 |
| 10724995165335 | NA | STERIS CORPORATION | 2021-04-02 |
| 00724995157906 | NA | STERIS CORPORATION | 2021-04-02 |
| 00815849021556 | Custom Medical Specialties, Inc. | CUSTOM ASSEMBLIES, INC. | 2016-11-21 |
| 00815849020177 | Custom Medical Specialties, Inc. | CUSTOM ASSEMBLIES, INC. | 2016-11-21 |
| 00815849020160 | Custom Medical Specialties, Inc. | CUSTOM ASSEMBLIES, INC. | 2016-11-21 |
| 00815849021839 | Custom Medical Specialties, Inc. | CUSTOM ASSEMBLIES, INC. | 2016-11-21 |