Browse hierarchy: [General, Plastic Surgery (SU)](/submissions/SU) → [Subpart E — Surgical Devices](/submissions/SU/subpart-e%E2%80%94surgical-devices) → [21 CFR 878.4950](/submissions/SU/subpart-e%E2%80%94surgical-devices/878.4950) → BWN — Table And Attachments, Operating-Room # BWN · Table And Attachments, Operating-Room _General, Plastic Surgery · 21 CFR 878.4950 · Class 1_ **Canonical URL:** https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/BWN ## Overview - **Product Code:** BWN - **Device Name:** Table And Attachments, Operating-Room - **Regulation:** [21 CFR 878.4950](/submissions/SU/subpart-e%E2%80%94surgical-devices/878.4950) - **Device Class:** 1 - **Review Panel:** [General, Plastic Surgery](/submissions/SU) ## 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 20) | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K942699](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/BWN/K942699.md) | AIRFRAME SURGICAL DRAPE SUPPORT | Alpha Surgical, Inc. | Jul 13, 1994 | SESE | | [K935441](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/BWN/K935441.md) | INFINITECH BREATH EZ | Infinitech, Inc. | Feb 7, 1994 | SESE | | [K925005](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/BWN/K925005.md) | ISI SELF-SUPPORTING ARM | Instrumentation Specialties, Inc. | Apr 29, 1993 | SESE | | [K922288](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/BWN/K922288.md) | HOLDER, PEDIATRIC POSITION | Yamashita and Hemsley Business Trust | Feb 10, 1993 | SESE | | [K910783](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/BWN/K910783.md) | SHAMPAINE MODEL 3800 OR MURANAKA MODEL OR-604M | Smith & Nephew Equipment Group | Apr 2, 1991 | SESE | | [K902865](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/BWN/K902865.md) | BAUMER SURGICAL TABLE | Sds Dental, Inc. | Sep 10, 1990 | SESE | | [K884558](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/BWN/K884558.md) | IOP ADJUSTABLE STIRRUP | Mend Technologies, Inc. | Nov 17, 1988 | SESE | | [K875291](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/BWN/K875291.md) | SPINAL SURGERY FRAME | T. Korossurgical Instruments Corp. | Jan 22, 1988 | SESE | | [K873272](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/BWN/K873272.md) | ENDOSCOPY TABLE 1532 ENDOSTAR | Stierlen-Maquet AG | Sep 8, 1987 | SESE | | [K860177](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/BWN/K860177.md) | ALLEN UNIVERSAL STIRRUP | Edgewater Medical Equipment Systems | Feb 11, 1986 | SESE | | [K852332](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/BWN/K852332.md) | TABLE ACCESSORIES, OPERATING ROOM | Scholten Surgical Instruments, Inc. | Jul 2, 1985 | SESE | | [K843121](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/BWN/K843121.md) | GUIDE TO THE KNEE | Dyonics, Inc. | Sep 7, 1984 | SESE | | [K832340](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/BWN/K832340.md) | OPERATING ROOM TABLES HYDRAULIC | Kamiya Tsusan Kaisha, Ltd. | Aug 12, 1983 | SESE | | [K823772](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/BWN/K823772.md) | AMSCO ORTHOGRAPHIC 2 TABLE | American Sterilizer Co. | Jan 14, 1983 | SESE | | [K820574](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/BWN/K820574.md) | ARMBOARD FOR INTRAVENOUS ANES. IN DENTAL | David Simmonds Co., Inc. | Mar 23, 1982 | SESE | | [K812396](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/BWN/K812396.md) | ARTHRO-PREP REST | Northwest Surgical Concepts, Inc. | Nov 20, 1981 | SESE | | [K812395](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/BWN/K812395.md) | ARTHRO-PREP REST W/STAND | Northwest Surgical Concepts, Inc. | Nov 20, 1981 | SESE | | [K802271](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/BWN/K802271.md) | THE IMMOBILIZER FOR OPEN & ARTHROSCOPIC | The Anspach Effort, Inc. | Oct 23, 1980 | SESE | | [K792569](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/BWN/K792569.md) | OPERATING TABLES & AMPLINOX 03 | Ets Rene Marzet | Jan 4, 1980 | SESE | | [K791859](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/BWN/K791859.md) | TECNOL STIRRUPS STRAP | Tecnol New Jersey Wound Care, Inc. | Oct 4, 1979 | SESE | ## Top Applicants - Northwest Surgical Concepts, Inc. — 2 clearances - Alpha Surgical, Inc. — 1 clearance - American Sterilizer Co. — 1 clearance - David Simmonds Co., Inc. — 1 clearance - Dyonics, Inc. — 1 clearance --- **Source:** [https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/BWN](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/BWN) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com