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.
Cleared Devices (110)
| 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 |
| K961683 | JJ SKINNER CAREKITS MINOR SURGICAL PROCEDURE TRAY | J.J. Skinner, Inc. | May 10, 1996 | SESE |
| K952539 | RADIOLOGY PACKS | Sterile Concepts, Inc. | Jul 14, 1995 | SESE |
| K951478 | GENERAL AND PLASTIC SURGERY PACKS | Sterile Concepts, Inc. | Jun 13, 1995 | SESE |
| K950295 | WOUND CLOSURE/LACERATION TRAY | Customed, Inc. | Apr 18, 1995 | SESE |
| K951149 | SINGLE USE INSTRUMENT TRAY | Medcare Custom Packaging, Inc. | Apr 6, 1995 | SESK |
| K950574 | NEEDLE/CANNULA | Tri-Med Specialties, Inc. | Feb 24, 1995 | SEKD |
| K945831 | DISPOSABLE JOINT ASPIRATION/INJECTION DIAGNOSTIC KIT | Micromed Development Corp. | Jan 20, 1995 | SESE |
| K945481 | SHAVE PREP KIT | Harding Industries, Inc. | Dec 23, 1994 | SESK |
| K945160 | PARACENTESIS NEEDLES/CANNULAS | Tri-Med Specialties, Inc. | Nov 14, 1994 | SESE |
| K944044 | CHIBA STYLE BIOPSY NEEDLE | Kormed, Inc. | Oct 3, 1994 | SEKD |
| K941846 | BONE MARROW BIOPSY TRAY | Kormed, Inc. | May 18, 1994 | SESE |
| K925467 | JJ SKINNER CAREKITS(TM) DRY/WET/GEL SKIN SCRUB KIT | J.J. Skinner, Inc. | May 11, 1994 | SEKD |
| K934688 | STERILE DESIGN | Sterile Design, Inc. | Mar 16, 1994 | SEKD |
| K935743 | INSTRUMENT TRAY | Cush Medical Products | Mar 3, 1994 | SESE |
| K936117 | CENTRAL LINE TRAY | Cush Medical Products | Mar 1, 1994 | SESE |
| K935686 | DRESSING CHANGE TRAY | Cush Medical Products | Feb 25, 1994 | SESK |
| K935858 | MILL-ROSE PERCUTANEOUS PROCEDURAL KIT | Mill-Rose Laboratory | Feb 22, 1994 | SEKD |
| K935740 | IRRIGATION TRAY | Cush Medical Products | Feb 22, 1994 | SESE |
| K933137 | ACU-SUTURE KIT | Acuderm, Inc. | Feb 22, 1994 | SESE |
| K934028 | STERILE DRESSING CHANGE TRAY | Surgipro, Inc. | Feb 17, 1994 | SEKD |
| K930270 | PATIENT PREOPERATIVE PREP TRAY, SINGLE USE | Professional Medical Products, Inc. | Feb 17, 1994 | SESE |
| K935741 | O.R. BASIN SET TRAY | Cush Medical Products | Feb 15, 1994 | SESE |
| K935483 | E-Z PREP(R) TRAY WITH HIBICLENS(R) | Bd Becton Dickinson Vacutainer Systems Preanalytic | Feb 9, 1994 | SESE |
| K931820 | CARAPACE STILLWATER BOWL SET | Carapace, Inc. | Feb 7, 1994 | SESK |
| K934029 | STERILE LACERATION & DEBRIDEMENT TRAYS | Surgipro, Inc. | Feb 4, 1994 | SESK |
| K931760 | CARAPACE PACKING GAUZE TRAYS | Carapace, Inc. | Feb 4, 1994 | SESK |
| K934030 | STERILE TRACHEOSTOMY TRAY | Surgipro, Inc. | Jan 26, 1994 | SEKD |
| K931758 | CARAPACE WOUND DRESSING KITS & LACERATION TRAYS | Carapace, Inc. | Jan 26, 1994 | SEKD |
| K920292 | VARIOUS KITS AND TRAYS | Professional Medical Products, Inc. | Jan 26, 1994 | SEKD |
| K931844 | CUSTOM PROCEDURE MEDICAL TRAY OR KIT | Custom Medical Products, Ltd. | Jan 25, 1994 | SEKD |
| K931759 | CARAPACE STERILE GAUZE TRAYS | Carapace, Inc. | Jan 25, 1994 | SESK |
| K934428 | ARGYLE TURKEL SAFETY PNEUMOTHORAX PROCEDURE TRAY | Sherwood Medical Co. | Dec 30, 1993 | SEKD |
| K931673 | CARAPACE CATARACT TRAYS | Carapace, Inc. | Dec 30, 1993 | SEKD |
| K931824 | CARAPACE INSTRUMLENT AND INSTRUMENT SETS | Carapace, Inc. | Dec 6, 1993 | SEKD |
| K932652 | TRI-MED PARACENTESIS TRAY | Tri-Med Specialties, Inc. | Nov 24, 1993 | SEKD |
| K932217 | MAJOR, MINOR, BASIN TRAYS (PACKS) | Associated Medical Products Co. | Nov 15, 1993 | SESK |
| K932220 | LAP CHOLY TRAYS (PACKS) | Associated Medical Products Co. | Sep 27, 1993 | SESK |
| K926269 | PROCEDURE KIT | General Medical Co. | Aug 27, 1993 | SEKD |
| K930700 | MEDLINES REPEAT PERFORMANCE SURGICAL PACK SYSTEM | Medline Industries, Inc. | Jul 9, 1993 | SESK |
| K924468 | STERILE INSTRUMENT TRAYS/BASIN SETS | Baxter Healthcare Corp | Jul 9, 1993 | SESE |
| K925214 | SHAVE PREP TRAYS (NON-STERILE) | American Healthcare Supply Co., Inc. | Jul 2, 1993 | SESK |
| K925216 | STERILE SKIN SCRUB TRAYS | American Healthcare Supply Co., Inc. | Jun 22, 1993 | SEKD |
| K914037 | MEDSURG O.R. PROCEDURE TRAY | Medsurg Industries, Inc. | Jun 22, 1993 | SEKD |
| K922133 | HOSPITAL KIT SV 105 | Savoy Medical Supply Co., Inc. | Jun 7, 1993 | SESK |
| K925016 | PREP SHAVE KIT (NON-STERILE) | Customed, Inc. | Apr 26, 1993 | SESE |
| K923600 | ENDO OPTIKS VALUE PACK | Endo Optics, Inc. | Mar 23, 1993 | SESK |
| K920267 | DYONICS ARTHROSCOPIC KIT | Smith & Nephew Dyonics, Inc. | Mar 23, 1993 | SEKD |
| K922648 | ACE CUSTOM SURGICAL PACK | Ace Surgical Supply Co., Inc. | Mar 20, 1993 | SESK |
| K914036 | MEDSURG LAPAROSCOPY TRAY | Medsurg Industries, Inc. | Mar 18, 1992 | SESE |
| K914174 | STERILE DISPOSABLE WET SKIN SCRUB TRAY | Medical Device Inspection Co., Inc. | Feb 24, 1992 | SEKD |
| K914935 | HEART PACK II | Westmark Hospital Supplies | Jan 31, 1992 | SEKD |
| K913136 | LASER ENDOSCOPE DISC DECOMPRESSION KITS | Medical Laser, Inc. | Nov 1, 1991 | SESK |
| K905459 | SURGICAL PROCEDURE TRAY/LAPAROSCOPY CHOLECYSTECTOM | Angiosystems, Inc. | Apr 5, 1991 | SESE |
| K910365 | WOUND CLOSURE KIT | Megadyne Medical Products, Inc. | Mar 28, 1991 | SESE |
| K910368 | MEGA LACERATION KIT | Megadyne Medical Products, Inc. | Mar 18, 1991 | SESE |
| K905004 | BIO-GUARD O.R. SCRUB PREP TRAY | Network Medical Systems, Inc. | Feb 21, 1991 | SESE |
| K902888 | CUSTOMED ORTHOPEDIC II | Customed, Inc. | Sep 10, 1990 | SESE |
| K902887 | CUSTOMED ARTHROSCOPY PACK | Customed, Inc. | Sep 10, 1990 | SESE |
| K903336 | CUSTOMED HIP PACT | Customed, Inc. | Aug 29, 1990 | SESE |
| K901856 | CUSTOM WOUND MANAGEMENT KITS AND TRAYS | Medcare Custom Packaging, Inc. | Aug 1, 1990 | SESD |
| K902293 | ANGIOGRAPHY DRAPE PACK | Biocor Medical, Inc. | Jul 19, 1990 | SESD |
| K890658 | SYRINGE INJECTION GUN DELIVERY KITS | Gastrotech, Inc. | Oct 3, 1989 | SESE |
| K895202 | 1420 HEEL-STICK(TM) NEONATAL BLOOD SAMPLING KIT | Transidyne General Corp. | Sep 15, 1989 | SESE |
| K894685 | DAVIS+GECK VISADUCT KIT | Davis & Geck, Inc. | Aug 22, 1989 | SESE |
| K893814 | SURGICAL INSTRUMENT KIT, DISPOSABLE | Bioseal | Aug 10, 1989 | SESE |
| K892389 | BIOPSY KIT | I M, Inc. | Jul 17, 1989 | SESD |
| K890570 | SKIN SCRUB KIT | Kit Pak, Inc. | May 5, 1989 | SESE |
| K890729 | SUTURE REMOVAL KIT | Cypress Medical Products, Ltd. | Apr 17, 1989 | SESE |
| K890726 | TRACHEOSTOMY CARE AND CLEANING KITS | Cypress Medical Products, Ltd. | Mar 10, 1989 | SESE |
| K885090 | HOMER MAMMALOK LOCALIZATION SHIELD | North American Instrument Corp. | Feb 14, 1989 | SESE |
| K890098 | KLEEN TEST O.R. KIT | Kleen Test Products | Jan 24, 1989 | SESE |
| K884093 | STERILE DISPOSABLE SURGICAL PACKS | Bolden Surgical Products | Oct 19, 1988 | SESE |
| K883250 | STERI-CLENS WOUND CARE KIT | Absorbent Cotton Co., Inc. | Aug 26, 1988 | SESE |
| K882684 | REPAK SURGICAL PACKS - GOWN/TOWEL/MAJOR/DRAPE/BAS. | Standard Textile Co., Inc. | Aug 3, 1988 | SESE |
| K880961 | ALCON SURGICAL PROCEDURE PACKS | Alcon Laboratories | Apr 29, 1988 | SESE |
| K881083 | GENERAL PURPOSE KIT | Med-Dex Intl. | Apr 7, 1988 | SESD |
| K880942 | REPAK SURGICAL PACK (GOWN,TOWEL,MAJOR,DRAPE,BASIC) | Repack Surgical Enterprises, Inc. | Mar 21, 1988 | SESE |
| K874760 | CK 4900 SERIES, GOWN AND TOWEL PAK | Currie Medical Specialties, Inc. | Dec 10, 1987 | SESE |
| K874439 | SOFT TISSUE ANCHORING SET KIT | Concept, Inc. | Nov 20, 1987 | SESE |
| K873973 | LAKE WOUND CARE/TREATMENT KIT | Lake Medical Products, Inc. | Nov 20, 1987 | SESE |
| K872448 | BLOOD CONTAINMENT PACK | Professional Medical Services | Nov 17, 1987 | SESE |
| K872011 | PORT ACCESS KITS | The Jarid Group, Inc. | Jul 13, 1987 | SESE |
| K871873 | CLOSED CHEST DRAINAGE SET | Gish Biomedical, Inc. | Jul 9, 1987 | SESE |
| K871437 | SURVIVAL KIT, INDIVIDUAL | Fraass Survival Systems, Inc. | Jul 9, 1987 | SESE |
| K871434 | MEDICAL PACKET, INDIVIDUAL SURVIVAL KIT, AIRMAN'S | Fraass Survival Systems, Inc. | Jul 9, 1987 | SESE |
| K871459 | SURVIVAL KIT, INDIV TROP TACT AIR CREW/PLASTIC BAG | Frass Survival Systems, Inc. | Jun 5, 1987 | SESD |
| K871322 | ADVANCED MEDICAL SYSTEMS, KIT | The Jarid Group, Inc. | May 27, 1987 | SESE |
| K854292 | MEDSURG ARTHROGRAM TRAY | Medsurg Industries, Inc. | Nov 26, 1985 | SESE |
| K854095 | BIOPSY TRAY I & II | North Coast Medi-Tek | Nov 25, 1985 | SESD |
| K842648 | GENERAL SURGERY TRAY | Deroyal Industries, Inc. | Sep 20, 1984 | 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
