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) → FWZ — Operating Room Accessories Table Tray # FWZ · Operating Room Accessories Table Tray _General, Plastic Surgery · 21 CFR 878.4950 · Class 1_ **Canonical URL:** https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/FWZ ## Overview - **Product Code:** FWZ - **Device Name:** Operating Room Accessories Table Tray - **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 61) Showing 20 most recent of 61 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K960019](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/FWZ/K960019.md) | RETRACTOR ARM CLAMP | Biopsys Medical, Inc. | Feb 9, 1996 | SESE | | [K945415](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/FWZ/K945415.md) | 'LIL MAC ACCESSORY CLAMP(TM) | D.L. Nelson and Assoc., Inc. | Nov 22, 1994 | SESE | | [K944779](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/FWZ/K944779.md) | CARBON LIGHTS HAND SURGERY TABLE | Allen Medical Systems, Inc. | Oct 14, 1994 | SESE | | [K935381](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/FWZ/K935381.md) | KAPS POSITIONING ARM | Andronic Devices, Ltd. | Apr 15, 1994 | SESE | | [K931037](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/FWZ/K931037.md) | WHITMORE VACUUM-LOCK SPINAL FRAME (VLSF-100) | Whitmore Ent., Inc. | Jul 30, 1993 | SESE | | [K926225](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/FWZ/K926225.md) | SPONGE COUNTER | American Medical Manufacturer, Inc. | Mar 5, 1993 | SESE | | [K925035](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/FWZ/K925035.md) | MIDKIFF GEOSTATIC CLAMP | D.L. Nelson and Assoc., Inc. | Feb 18, 1993 | SESE | | [K905565](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/FWZ/K905565.md) | LATERAL BUTTRESS SUPPORT | Mcconnell Orthopedic | Feb 21, 1991 | SESE | | [K905564](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/FWZ/K905564.md) | PREP AND OPERATING STAND | Mcconnell Orthopedic | Feb 21, 1991 | SESE | | [K910031](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/FWZ/K910031.md) | PARK CITY SHOULDER POSITIONER | Orthopedic Systems, Inc. | Jan 24, 1991 | SESE | | [K904826](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/FWZ/K904826.md) | TKO TELESCOPING LITHOTOMY STIRRUP | D.L. Nelson and Assoc., Inc. | Oct 31, 1990 | SESE | | [K897028](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/FWZ/K897028.md) | LINCOLN MILLS FOOT AND LEG HOLDER | Lincoln Mills, Inc. | Jan 12, 1990 | SESE | | [K893969](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/FWZ/K893969.md) | DECUBITUS CARE PAD | Gulftrade Exim, Inc. | Jul 14, 1989 | SESE | | [K890501](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/FWZ/K890501.md) | SECOND ASSISTANT | 3M Company | Feb 10, 1989 | SESE | | [K885215](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/FWZ/K885215.md) | LINCOLN MILLS HIP HOLDER | Lincoln Mills, Inc. | Jan 13, 1989 | SESE | | [K884928](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/FWZ/K884928.md) | FREE ARM(TM) | Faro Medical Technologies, Inc. | Dec 15, 1988 | SESE | | [K882078](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/FWZ/K882078.md) | SPINAL SURGERY FRAME | Karlin Technology, Inc. | Jun 16, 1988 | SESE | | [K880265](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/FWZ/K880265.md) | WEHBE ARM HOLDER | Orthopedic Systems, Inc. | Feb 18, 1988 | SESE | | [K873139](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/FWZ/K873139.md) | VARUS AND VALGUS LEG HOLDER | Leonard Medical, Inc. | Sep 16, 1987 | SESE | | [K873370](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/FWZ/K873370.md) | 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 --- **Source:** [https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/FWZ](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/FWZ) **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