LRO · General Surgery Tray
General, Plastic Surgery · 21 CFR 878.4370 · Class 2
Overview
| Product Code | LRO |
|---|---|
| Device Name | General Surgery Tray |
| Regulation | 21 CFR 878.4370 |
| Device Class | Class 2 |
| Review Panel | General, Plastic Surgery |
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 | Medline General Surgery Tray | Medline Industries, Inc. | May 24, 2022 | SESE |
| K212258 | Medline Cardiovascular Procedure Kit | Medline Industries, Inc. | Dec 3, 2021 | SESE |
| K041080 | SURGICAL DRAPE KIT - D.I.R.R.A. SRL | D.I.R.R.A. S.R.L. | Nov 30, 2004 | SESE |
| K030721 | QUICK-TAP PARACENTESIS TRAY, KIT & NEEDLE | Ballard Medical Products | Mar 31, 2003 | SESE |
| K023276 | AMSINO TRACHEOSTOMY CARE TRAY | Amsino International, Inc. | Dec 9, 2002 | SESE |
| K980137 | WORLDWIDE MEDICAL TECHNOLOGIES BONE MARROW BIOPSY PROCEDURE TRAY | Worldwide Medical Technologies, LLC | Jan 30, 1998 | SESE |
| K971061 | OPPORTUNITY INC. BONE MARROW BIOPSY AND ASPIRATION TRAY | Opportunity, Inc. | Jun 11, 1997 | SN |
| K971062 | OPPORTUNITY INC. GENERAL PURPOSE TRAY | Opportunity, Inc. | Jun 9, 1997 | SN |
| K932221 | NEUROLOGICAL OR CRANI TRAYS (PACKS) | Associated Medical Products Co. | Mar 19, 1997 | SESE |
| K970286 | PRESBYTERIAN LINEN SERVICES SURGICAL PACKS | Medline Industries, Inc. | Mar 10, 1997 | SESE |
| K970187 | RUNYON LARGE VOLUME PARACENTESIS KIT | Gi Supply | Feb 14, 1997 | SESE |
| K965201 | O.R. SCRUB PREP TRAY, STERILE, DISPOSABLE | Trinity Laboratories, Inc. | Feb 14, 1997 | SEKD |
| K964921 | BASIC BIOPSY TRAY. DISPOSABLE, STERILE | Trinity Laboratories, Inc. | Jan 22, 1997 | SESE |
| K963721 | SKIN SCRUB TRAY | Grand Medical Products | Nov 27, 1996 | SESE |
| K963715 | DEBRIDEMENT TRAY, INCISION AND DRAINAGE TRAY | Grand Medical Products | Nov 27, 1996 | SESE |
| K964011 | SUCTION CATHETER TRAY PRODUCT NO. 900277 | Customed, Inc. | Nov 25, 1996 | SESK |
| K963443 | PROD. NO. 02-031 - LACERATION TRAY | Continental Medical Laboratories, Inc. | Oct 17, 1996 | SESE |
| K962826 | MEDLINE RADIOLOGY-DIAGNOSTIC KITS | Medline Industries, Inc. | Sep 16, 1996 | SESE |
| K961863 | PARACENTESIS TRAYS | Tri-Med, Inc. | May 28, 1996 | SESE |
| K953083 | 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
