Browse hierarchy: [General, Plastic Surgery (SU)](/submissions/SU) → [Subpart E — Surgical Devices](/submissions/SU/subpart-e%E2%80%94surgical-devices) → [21 CFR 878.4370](/submissions/SU/subpart-e%E2%80%94surgical-devices/878.4370) → LRO — General Surgery Tray # LRO · General Surgery Tray _General, Plastic Surgery · 21 CFR 878.4370 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/LRO ## Overview - **Product Code:** LRO - **Device Name:** General Surgery Tray - **Regulation:** [21 CFR 878.4370](/submissions/SU/subpart-e%E2%80%94surgical-devices/878.4370) - **Device Class:** 2 - **Review Panel:** [General, Plastic Surgery](/submissions/SU) ## Identification A surgical drape and drape accessories is a device made of natural or synthetic materials intended to be used as a protective patient covering, such as to isolate a site of surgical incision from microbial and other contamination. The device includes a plastic wound protector that may adhere to the skin around a surgical incision or be placed in a wound to cover its exposed edges, and a latex drape with a self-retaining finger cot that is intended to allow repeated insertion of the surgeon's finger into the rectum during performance of a transurethral prostatectomy. ## Classification Rationale Class II (special controls). The device, when it is an ear, nose, and throat surgical drape, a latex sheet drape with self-retaining finger cot, a disposable urological drape, a Kelly pad, an ophthalmic patient drape, an ophthalmic microscope drape, an internal drape retention ring (wound protector), or a surgical drape that does not include an antimicrobial agent, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 878.9. ## Special Controls *Classification.* Class II (special controls). The device, when it is an ear, nose, and throat surgical drape, a latex sheet drape with self-retaining finger cot, a disposable urological drape, a Kelly pad, an ophthalmic patient drape, an ophthalmic microscope drape, an internal drape retention ring (wound protector), or a surgical drape that does not include an antimicrobial agent, 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 110) Showing 20 most recent of 110 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K213481](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/LRO/K213481.md) | Medline General Surgery Tray | Medline Industries, Inc. | May 24, 2022 | SESE | | [K212258](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/LRO/K212258.md) | Medline Cardiovascular Procedure Kit | Medline Industries, Inc. | Dec 3, 2021 | SESE | | [K041080](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/LRO/K041080.md) | SURGICAL DRAPE KIT - D.I.R.R.A. SRL | D.I.R.R.A. S.R.L. | Nov 30, 2004 | SESE | | [K030721](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/LRO/K030721.md) | QUICK-TAP PARACENTESIS TRAY, KIT & NEEDLE | Ballard Medical Products | Mar 31, 2003 | SESE | | [K023276](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/LRO/K023276.md) | AMSINO TRACHEOSTOMY CARE TRAY | Amsino International, Inc. | Dec 9, 2002 | SESE | | [K980137](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/LRO/K980137.md) | WORLDWIDE MEDICAL TECHNOLOGIES BONE MARROW BIOPSY PROCEDURE TRAY | Worldwide Medical Technologies, LLC | Jan 30, 1998 | SESE | | [K971061](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/LRO/K971061.md) | OPPORTUNITY INC. BONE MARROW BIOPSY AND ASPIRATION TRAY | Opportunity, Inc. | Jun 11, 1997 | SN | | [K971062](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/LRO/K971062.md) | OPPORTUNITY INC. GENERAL PURPOSE TRAY | Opportunity, Inc. | Jun 9, 1997 | SN | | [K932221](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/LRO/K932221.md) | NEUROLOGICAL OR CRANI TRAYS (PACKS) | Associated Medical Products Co. | Mar 19, 1997 | SESE | | [K970286](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/LRO/K970286.md) | PRESBYTERIAN LINEN SERVICES SURGICAL PACKS | Medline Industries, Inc. | Mar 10, 1997 | SESE | | [K970187](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/LRO/K970187.md) | RUNYON LARGE VOLUME PARACENTESIS KIT | Gi Supply | Feb 14, 1997 | SESE | | [K965201](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/LRO/K965201.md) | O.R. SCRUB PREP TRAY, STERILE, DISPOSABLE | Trinity Laboratories, Inc. | Feb 14, 1997 | SEKD | | [K964921](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/LRO/K964921.md) | BASIC BIOPSY TRAY. DISPOSABLE, STERILE | Trinity Laboratories, Inc. | Jan 22, 1997 | SESE | | [K963721](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/LRO/K963721.md) | SKIN SCRUB TRAY | Grand Medical Products | Nov 27, 1996 | SESE | | [K963715](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/LRO/K963715.md) | DEBRIDEMENT TRAY, INCISION AND DRAINAGE TRAY | Grand Medical Products | Nov 27, 1996 | SESE | | [K964011](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/LRO/K964011.md) | SUCTION CATHETER TRAY PRODUCT NO. 900277 | Customed, Inc. | Nov 25, 1996 | SESK | | [K963443](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/LRO/K963443.md) | PROD. NO. 02-031 - LACERATION TRAY | Continental Medical Laboratories, Inc. | Oct 17, 1996 | SESE | | [K962826](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/LRO/K962826.md) | MEDLINE RADIOLOGY-DIAGNOSTIC KITS | Medline Industries, Inc. | Sep 16, 1996 | SESE | | [K961863](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/LRO/K961863.md) | PARACENTESIS TRAYS | Tri-Med, Inc. | May 28, 1996 | SESE | | [K953083](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/LRO/K953083.md) | HOSPITAL LAUNDRY SERVICES SURGICAL PACKS | Hospital Laundry Services | May 14, 1996 | SESE | ## Top Applicants - Customed, Inc. — 6 clearances - Carapace, Inc. — 6 clearances - Medline Industries, Inc. — 5 clearances - Cush Medical Products — 5 clearances - Tri-Med Specialties, Inc. — 3 clearances --- **Source:** [https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/LRO](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/LRO) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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