Product Code: LRO
FDA class 2
21 CFR 878.4370
General Surgery Tray
General, Plastic Surgery
The General Surgery Tray is a prepackaged, sterile convenience kit containing assorted instruments and supplies used during general surgical procedures, assembled to streamline the preparation of the surgical field. This product code was established in accordance with the May 20, 1997 FDA guidance on convenience kits interim regulatory guidance, which outlines requirements for devices packaged together. It is classified as a Class 2 (moderate risk) device, subject to general and special controls, and requires 510(k) premarket notification. The product code is LRO, regulated under 21 CFR 878.4370, within the General and Plastic Surgery medical specialty. No special flags apply to this device.
510(k)s
110
FEI Numbers
165
Registration Numbers
165
Unique Applicants
72
Years Active
38
Basic Information
- Product Code
- LRO
- Device Class
- FDA class 2
- Regulation Number
- 878.4370
- Medical Specialty
- General, Plastic Surgery
- Review Panel
- SU
- Submission Type
- 7
Device Characteristics
✗
GMP Exempt
✗
Implant
✗
Life Sustain/Support
✗
Third Party
—
Summary Malfunction Reporting
Definition
This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance
510(k) Clearance History
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Related 510(k) Clearances
This FDA classification is associated with 110 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K213481 | Medline General Surgery Tray | May 24, 2022 | Substantially Equivalent | Medline Industries, Inc. |
| K212258 | Medline Cardiovascular Procedure Kit | Dec 03, 2021 | Substantially Equivalent | Medline Industries, Inc. |
| K041080 | SURGICAL DRAPE KIT - D.I.R.R.A. SRL | Nov 30, 2004 | Substantially Equivalent | D.I.R.R.A. S.R.L. |
| K030721 | QUICK-TAP PARACENTESIS TRAY, KIT & NEEDLE | Mar 31, 2003 | Substantially Equivalent | BALLARD MEDICAL PRODUCTS |
| K023276 | AMSINO TRACHEOSTOMY CARE TRAY | Dec 09, 2002 | Substantially Equivalent | AMSINO INTERNATIONAL, INC. |
| K980137 | WORLDWIDE MEDICAL TECHNOLOGIES BONE MARROW BIOPSY PROCEDURE TRAY | Jan 30, 1998 | Substantially Equivalent | WORLDWIDE MEDICAL TECHNOLOGIES, LLC |
| K971061 | OPPORTUNITY INC. BONE MARROW BIOPSY AND ASPIRATION TRAY | Jun 11, 1997 | Substantially Equivalent for Some Indications | OPPORTUNITY, INC. |
| K971062 | OPPORTUNITY INC. GENERAL PURPOSE TRAY | Jun 09, 1997 | Substantially Equivalent for Some Indications | OPPORTUNITY, INC. |
| K932221 | NEUROLOGICAL OR CRANI TRAYS (PACKS) | Mar 19, 1997 | Substantially Equivalent | ASSOCIATED MEDICAL PRODUCTS CO. |
| K970286 | PRESBYTERIAN LINEN SERVICES SURGICAL PACKS | Mar 10, 1997 | Substantially Equivalent | MEDLINE INDUSTRIES, INC. |
| K970187 | RUNYON LARGE VOLUME PARACENTESIS KIT | Feb 14, 1997 | Substantially Equivalent | GI SUPPLY |
| K965201 | O.R. SCRUB PREP TRAY, STERILE, DISPOSABLE | Feb 14, 1997 | Unknown | TRINITY LABORATORIES, INC. |
| K964921 | BASIC BIOPSY TRAY. DISPOSABLE, STERILE | Jan 22, 1997 | Substantially Equivalent | TRINITY LABORATORIES, INC. |
| K963721 | SKIN SCRUB TRAY | Nov 27, 1996 | Substantially Equivalent | GRAND MEDICAL PRODUCTS |
| K963715 | DEBRIDEMENT TRAY, INCISION AND DRAINAGE TRAY | Nov 27, 1996 | Substantially Equivalent | GRAND MEDICAL PRODUCTS |
| K964011 | SUCTION CATHETER TRAY PRODUCT NO. 900277 | Nov 25, 1996 | Unknown | CUSTOMED, INC. |
| K963443 | PROD. NO. 02-031 - LACERATION TRAY | Oct 17, 1996 | Substantially Equivalent | CONTINENTAL MEDICAL LABORATORIES, INC. |
| K962826 | MEDLINE RADIOLOGY-DIAGNOSTIC KITS | Sep 16, 1996 | Substantially Equivalent | MEDLINE INDUSTRIES, INC. |
| K961863 | PARACENTESIS TRAYS | May 28, 1996 | Substantially Equivalent | TRI-MED, INC. |
| K953083 | HOSPITAL LAUNDRY SERVICES SURGICAL PACKS | May 14, 1996 | Substantially Equivalent | HOSPITAL LAUNDRY SERVICES |
| K961683 | JJ SKINNER CAREKITS MINOR SURGICAL PROCEDURE TRAY | May 10, 1996 | Substantially Equivalent | J.J. SKINNER, INC. |
| K952539 | RADIOLOGY PACKS | Jul 14, 1995 | Substantially Equivalent | STERILE CONCEPTS, INC. |
| K951478 | GENERAL AND PLASTIC SURGERY PACKS | Jun 13, 1995 | Substantially Equivalent | STERILE CONCEPTS, INC. |
| K950295 | WOUND CLOSURE/LACERATION TRAY | Apr 18, 1995 | Substantially Equivalent | CUSTOMED, INC. |
| K951149 | SINGLE USE INSTRUMENT TRAY | Apr 06, 1995 | Unknown | MEDCARE CUSTOM PACKAGING, INC. |
| K950574 | NEEDLE/CANNULA | Feb 24, 1995 | Unknown | TRI-MED SPECIALTIES, INC. |
| K945831 | DISPOSABLE JOINT ASPIRATION/INJECTION DIAGNOSTIC KIT | Jan 20, 1995 | Substantially Equivalent | MICROMED DEVELOPMENT CORP. |
| K945481 | SHAVE PREP KIT | Dec 23, 1994 | Unknown | HARDING INDUSTRIES, INC. |
| K945160 | PARACENTESIS NEEDLES/CANNULAS | Nov 14, 1994 | Substantially Equivalent | TRI-MED SPECIALTIES, INC. |
| K944044 | CHIBA STYLE BIOPSY NEEDLE | Oct 03, 1994 | Unknown | KORMED, INC. |
| K941846 | BONE MARROW BIOPSY TRAY | May 18, 1994 | Substantially Equivalent | KORMED, INC. |
| K925467 | JJ SKINNER CAREKITS(TM) DRY/WET/GEL SKIN SCRUB KIT | May 11, 1994 | Unknown | J.J. SKINNER, INC. |
| K934688 | STERILE DESIGN | Mar 16, 1994 | Unknown | STERILE DESIGN, INC. |
| K935743 | INSTRUMENT TRAY | Mar 03, 1994 | Substantially Equivalent | CUSH MEDICAL PRODUCTS |
| K936117 | CENTRAL LINE TRAY | Mar 01, 1994 | Substantially Equivalent | CUSH MEDICAL PRODUCTS |
| K935686 | DRESSING CHANGE TRAY | Feb 25, 1994 | Unknown | CUSH MEDICAL PRODUCTS |
| K935858 | MILL-ROSE PERCUTANEOUS PROCEDURAL KIT | Feb 22, 1994 | Unknown | MILL-ROSE LABORATORY |
| K935740 | IRRIGATION TRAY | Feb 22, 1994 | Substantially Equivalent | CUSH MEDICAL PRODUCTS |
| K933137 | ACU-SUTURE KIT | Feb 22, 1994 | Substantially Equivalent | ACUDERM, INC. |
| K934028 | STERILE DRESSING CHANGE TRAY | Feb 17, 1994 | Unknown | SURGIPRO, INC. |
| K930270 | PATIENT PREOPERATIVE PREP TRAY, SINGLE USE | Feb 17, 1994 | Substantially Equivalent | PROFESSIONAL MEDICAL PRODUCTS, INC. |
| K935741 | O.R. BASIN SET TRAY | Feb 15, 1994 | Substantially Equivalent | CUSH MEDICAL PRODUCTS |
| K935483 | E-Z PREP(R) TRAY WITH HIBICLENS(R) | Feb 09, 1994 | Substantially Equivalent | BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC |
| K931820 | CARAPACE STILLWATER BOWL SET | Feb 07, 1994 | Unknown | CARAPACE, INC. |
| K934029 | STERILE LACERATION & DEBRIDEMENT TRAYS | Feb 04, 1994 | Unknown | SURGIPRO, INC. |
| K931760 | CARAPACE PACKING GAUZE TRAYS | Feb 04, 1994 | Unknown | CARAPACE, INC. |
| K934030 | STERILE TRACHEOSTOMY TRAY | Jan 26, 1994 | Unknown | SURGIPRO, INC. |
| K931758 | CARAPACE WOUND DRESSING KITS & LACERATION TRAYS | Jan 26, 1994 | Unknown | CARAPACE, INC. |
| K920292 | VARIOUS KITS AND TRAYS | Jan 26, 1994 | Unknown | PROFESSIONAL MEDICAL PRODUCTS, INC. |
| K931844 | CUSTOM PROCEDURE MEDICAL TRAY OR KIT | Jan 25, 1994 | Unknown | CUSTOM MEDICAL PRODUCTS, LTD. |
| K931759 | CARAPACE STERILE GAUZE TRAYS | Jan 25, 1994 | Unknown | CARAPACE, INC. |
| K934428 | ARGYLE TURKEL SAFETY PNEUMOTHORAX PROCEDURE TRAY | Dec 30, 1993 | Unknown | SHERWOOD MEDICAL CO. |
| K931673 | CARAPACE CATARACT TRAYS | Dec 30, 1993 | Unknown | CARAPACE, INC. |
| K931824 | CARAPACE INSTRUMLENT AND INSTRUMENT SETS | Dec 06, 1993 | Unknown | CARAPACE, INC. |
| K932652 | TRI-MED PARACENTESIS TRAY | Nov 24, 1993 | Unknown | TRI-MED SPECIALTIES, INC. |
| K932217 | MAJOR, MINOR, BASIN TRAYS (PACKS) | Nov 15, 1993 | Unknown | ASSOCIATED MEDICAL PRODUCTS CO. |
| K932220 | LAP CHOLY TRAYS (PACKS) | Sep 27, 1993 | Unknown | ASSOCIATED MEDICAL PRODUCTS CO. |
| K926269 | PROCEDURE KIT | Aug 27, 1993 | Unknown | GENERAL MEDICAL CO. |
| K930700 | MEDLINES REPEAT PERFORMANCE SURGICAL PACK SYSTEM | Jul 09, 1993 | Unknown | MEDLINE INDUSTRIES, INC. |
| K924468 | STERILE INSTRUMENT TRAYS/BASIN SETS | Jul 09, 1993 | Substantially Equivalent | BAXTER HEALTHCARE CORP. |
| K925214 | SHAVE PREP TRAYS (NON-STERILE) | Jul 02, 1993 | Unknown | AMERICAN HEALTHCARE SUPPLY CO., INC. |
| K925216 | STERILE SKIN SCRUB TRAYS | Jun 22, 1993 | Unknown | AMERICAN HEALTHCARE SUPPLY CO., INC. |
| K914037 | MEDSURG O.R. PROCEDURE TRAY | Jun 22, 1993 | Unknown | MEDSURG INDUSTRIES, INC. |
| K922133 | HOSPITAL KIT SV 105 | Jun 07, 1993 | Unknown | SAVOY MEDICAL SUPPLY CO., INC. |
| K925016 | PREP SHAVE KIT (NON-STERILE) | Apr 26, 1993 | Substantially Equivalent | CUSTOMED, INC. |
| K923600 | ENDO OPTIKS VALUE PACK | Mar 23, 1993 | Unknown | ENDO OPTICS, INC. |
| K920267 | DYONICS ARTHROSCOPIC KIT | Mar 23, 1993 | Unknown | SMITH & NEPHEW DYONICS, INC. |
| K922648 | ACE CUSTOM SURGICAL PACK | Mar 20, 1993 | Unknown | ACE SURGICAL SUPPLY CO., INC. |
| K914036 | MEDSURG LAPAROSCOPY TRAY | Mar 18, 1992 | Substantially Equivalent | MEDSURG INDUSTRIES, INC. |
| K914174 | STERILE DISPOSABLE WET SKIN SCRUB TRAY | Feb 24, 1992 | Unknown | MEDICAL DEVICE INSPECTION CO., INC. |
| K914935 | HEART PACK II | Jan 31, 1992 | Unknown | WESTMARK HOSPITAL SUPPLIES |
| K913136 | LASER ENDOSCOPE DISC DECOMPRESSION KITS | Nov 01, 1991 | Unknown | MEDICAL LASER, INC. |
| K905459 | SURGICAL PROCEDURE TRAY/LAPAROSCOPY CHOLECYSTECTOM | Apr 05, 1991 | Substantially Equivalent | ANGIOSYSTEMS, INC. |
| K910365 | WOUND CLOSURE KIT | Mar 28, 1991 | Substantially Equivalent | MEGADYNE MEDICAL PRODUCTS, INC. |
| K910368 | MEGA LACERATION KIT | Mar 18, 1991 | Substantially Equivalent | MEGADYNE MEDICAL PRODUCTS, INC. |
| K905004 | BIO-GUARD O.R. SCRUB PREP TRAY | Feb 21, 1991 | Substantially Equivalent | NETWORK MEDICAL SYSTEMS, INC. |
| K902888 | CUSTOMED ORTHOPEDIC II | Sep 10, 1990 | Substantially Equivalent | CUSTOMED, INC. |
| K902887 | CUSTOMED ARTHROSCOPY PACK | Sep 10, 1990 | Substantially Equivalent | CUSTOMED, INC. |
| K903336 | CUSTOMED HIP PACT | Aug 29, 1990 | Substantially Equivalent | CUSTOMED, INC. |
| K901856 | CUSTOM WOUND MANAGEMENT KITS AND TRAYS | Aug 01, 1990 | Unknown | MEDCARE CUSTOM PACKAGING, INC. |
| K902293 | ANGIOGRAPHY DRAPE PACK | Jul 19, 1990 | Unknown | BIOCOR MEDICAL, INC. |
| K890658 | SYRINGE INJECTION GUN DELIVERY KITS | Oct 03, 1989 | Substantially Equivalent | GASTROTECH, INC. |
| K895202 | 1420 HEEL-STICK(TM) NEONATAL BLOOD SAMPLING KIT | Sep 15, 1989 | Substantially Equivalent | TRANSIDYNE GENERAL CORP. |
| K894685 | DAVIS+GECK VISADUCT KIT | Aug 22, 1989 | Substantially Equivalent | DAVIS & GECK, INC. |
| K893814 | SURGICAL INSTRUMENT KIT, DISPOSABLE | Aug 10, 1989 | Substantially Equivalent | BIOSEAL |
| K892389 | BIOPSY KIT | Jul 17, 1989 | Unknown | I M, INC. |
| K890570 | SKIN SCRUB KIT | May 05, 1989 | Substantially Equivalent | KIT PAK, INC. |
| K890729 | SUTURE REMOVAL KIT | Apr 17, 1989 | Substantially Equivalent | CYPRESS MEDICAL PRODUCTS, LTD. |
| K890726 | TRACHEOSTOMY CARE AND CLEANING KITS | Mar 10, 1989 | Substantially Equivalent | CYPRESS MEDICAL PRODUCTS, LTD. |
| K885090 | HOMER MAMMALOK LOCALIZATION SHIELD | Feb 14, 1989 | Substantially Equivalent | NORTH AMERICAN INSTRUMENT CORP. |
| K890098 | KLEEN TEST O.R. KIT | Jan 24, 1989 | Substantially Equivalent | KLEEN TEST PRODUCTS |
| K884093 | STERILE DISPOSABLE SURGICAL PACKS | Oct 19, 1988 | Substantially Equivalent | BOLDEN SURGICAL PRODUCTS |
| K883250 | STERI-CLENS WOUND CARE KIT | Aug 26, 1988 | Substantially Equivalent | ABSORBENT COTTON CO., INC. |
| K882684 | REPAK SURGICAL PACKS - GOWN/TOWEL/MAJOR/DRAPE/BAS. | Aug 03, 1988 | Substantially Equivalent | STANDARD TEXTILE CO., INC. |
| K880961 | ALCON SURGICAL PROCEDURE PACKS | Apr 29, 1988 | Substantially Equivalent | ALCON LABORATORIES |
| K881083 | GENERAL PURPOSE KIT | Apr 07, 1988 | Unknown | MED-DEX INTL. |
| K880942 | REPAK SURGICAL PACK (GOWN,TOWEL,MAJOR,DRAPE,BASIC) | Mar 21, 1988 | Substantially Equivalent | REPACK SURGICAL ENTERPRISES, INC. |
| K874760 | CK 4900 SERIES, GOWN AND TOWEL PAK | Dec 10, 1987 | Substantially Equivalent | CURRIE MEDICAL SPECIALTIES, INC. |
| K874439 | SOFT TISSUE ANCHORING SET KIT | Nov 20, 1987 | Substantially Equivalent | CONCEPT, INC. |
| K873973 | LAKE WOUND CARE/TREATMENT KIT | Nov 20, 1987 | Substantially Equivalent | LAKE MEDICAL PRODUCTS, INC. |
| K872448 | BLOOD CONTAINMENT PACK | Nov 17, 1987 | Substantially Equivalent | PROFESSIONAL MEDICAL SERVICES |
| K872011 | PORT ACCESS KITS | Jul 13, 1987 | Substantially Equivalent | THE JARID GROUP, INC. |
| K871873 | CLOSED CHEST DRAINAGE SET | Jul 09, 1987 | Substantially Equivalent | GISH BIOMEDICAL, INC. |
| K871437 | SURVIVAL KIT, INDIVIDUAL | Jul 09, 1987 | Substantially Equivalent | FRAASS SURVIVAL SYSTEMS, INC. |
| K871434 | MEDICAL PACKET, INDIVIDUAL SURVIVAL KIT, AIRMAN'S | Jul 09, 1987 | Substantially Equivalent | FRAASS SURVIVAL SYSTEMS, INC. |
| K871459 | SURVIVAL KIT, INDIV TROP TACT AIR CREW/PLASTIC BAG | Jun 05, 1987 | Unknown | FRASS SURVIVAL SYSTEMS, INC. |
| K871322 | ADVANCED MEDICAL SYSTEMS, KIT | May 27, 1987 | Substantially Equivalent | THE JARID GROUP, INC. |
| K854292 | MEDSURG ARTHROGRAM TRAY | Nov 26, 1985 | Substantially Equivalent | MEDSURG INDUSTRIES, INC. |
| K854095 | BIOPSY TRAY I & II | Nov 25, 1985 | Unknown | NORTH COAST MEDI-TEK |
| K842648 | GENERAL SURGERY TRAY | Sep 20, 1984 | Substantially Equivalent | DEROYAL INDUSTRIES, INC. |
FEI Numbers
This FDA classification entry is associated with 165 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 165 registration numbers. Click on an entry to view related FDA registrations.