FDA Product Code
FDA Product Code LRO — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- General, Plastic Surgery
- 21 CFR Citation
- 878.4370
510(k) Clearances — 110 records · page 1 of 2
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K213481 | Medline General Surgery Tray | Medline Industries, Inc. | 2022-05-24 | Traditional | PDF ↗ |
| K212258 | Medline Cardiovascular Procedure Kit | Medline Industries, Inc. | 2021-12-03 | Traditional | PDF ↗ |
| K041080 | SURGICAL DRAPE KIT - D.I.R.R.A. SRL | D.I.R.R.A. S.R.L. | 2004-11-30 | Traditional | PDF ↗ |
| K030721 | QUICK-TAP PARACENTESIS TRAY, KIT & NEEDLE | Ballard Medical Products | 2003-03-31 | Special | PDF ↗ |
| K023276 | AMSINO TRACHEOSTOMY CARE TRAY | Amsino International, Inc. | 2002-12-09 | Traditional | PDF ↗ |
| K980137 | WORLDWIDE MEDICAL TECHNOLOGIES BONE MARROW BIOPSY PROCEDURE TRAY | Worldwide Medical Technologies, LLC | 1998-01-30 | Traditional | PDF ↗ |
| K971061 | OPPORTUNITY INC. BONE MARROW BIOPSY AND ASPIRATION TRAY | Opportunity, Inc. | 1997-06-11 | Traditional | PDF ↗ |
| K971062 | OPPORTUNITY INC. GENERAL PURPOSE TRAY | Opportunity, Inc. | 1997-06-09 | Traditional | PDF ↗ |
| K932221 | NEUROLOGICAL OR CRANI TRAYS (PACKS) | Associated Medical Products Co. | 1997-03-19 | Traditional | PDF ↗ |
| K970286 | PRESBYTERIAN LINEN SERVICES SURGICAL PACKS | Medline Industries, Inc. | 1997-03-10 | Traditional | PDF ↗ |
| K965201 | O.R. SCRUB PREP TRAY, STERILE, DISPOSABLE | Trinity Laboratories, Inc. | 1997-02-14 | Traditional | PDF ↗ |
| K970187 | RUNYON LARGE VOLUME PARACENTESIS KIT | Gi Supply | 1997-02-14 | Traditional | PDF ↗ |
| K964921 | BASIC BIOPSY TRAY. DISPOSABLE, STERILE | Trinity Laboratories, Inc. | 1997-01-22 | Traditional | PDF ↗ |
| K963721 | SKIN SCRUB TRAY | Grand Medical Products | 1996-11-27 | Traditional | PDF ↗ |
| K963715 | DEBRIDEMENT TRAY, INCISION AND DRAINAGE TRAY | Grand Medical Products | 1996-11-27 | Traditional | PDF ↗ |
| K964011 | SUCTION CATHETER TRAY PRODUCT NO. 900277 | Customed, Inc. | 1996-11-25 | Traditional | PDF ↗ |
| K963443 | PROD. NO. 02-031 - LACERATION TRAY | Continental Medical Laboratories, Inc. | 1996-10-17 | Traditional | PDF ↗ |
| K962826 | MEDLINE RADIOLOGY-DIAGNOSTIC KITS | Medline Industries, Inc. | 1996-09-16 | Traditional | PDF ↗ |
| K961863 | PARACENTESIS TRAYS | Tri-Med, Inc. | 1996-05-28 | Traditional | PDF ↗ |
| K953083 | HOSPITAL LAUNDRY SERVICES SURGICAL PACKS | Hospital Laundry Services | 1996-05-14 | Traditional | PDF ↗ |
| K961683 | JJ SKINNER CAREKITS MINOR SURGICAL PROCEDURE TRAY | J.J. Skinner, Inc. | 1996-05-10 | Traditional | PDF ↗ |
| K952539 | RADIOLOGY PACKS | Sterile Concepts, Inc. | 1995-07-14 | Traditional | PDF ↗ |
| K951478 | GENERAL AND PLASTIC SURGERY PACKS | Sterile Concepts, Inc. | 1995-06-13 | Traditional | PDF ↗ |
| K950295 | WOUND CLOSURE/LACERATION TRAY | Customed, Inc. | 1995-04-18 | Traditional | PDF ↗ |
| K951149 | SINGLE USE INSTRUMENT TRAY | Medcare Custom Packaging, Inc. | 1995-04-06 | Traditional | PDF ↗ |
| K950574 | NEEDLE/CANNULA | Tri-Med Specialties, Inc. | 1995-02-24 | Traditional | PDF ↗ |
| K945831 | DISPOSABLE JOINT ASPIRATION/INJECTION DIAGNOSTIC KIT | Micromed Development Corp. | 1995-01-20 | Traditional | PDF ↗ |
| K945481 | SHAVE PREP KIT | Harding Industries, Inc. | 1994-12-23 | Traditional | PDF ↗ |
| K945160 | PARACENTESIS NEEDLES/CANNULAS | Tri-Med Specialties, Inc. | 1994-11-14 | Traditional | PDF ↗ |
| K944044 | CHIBA STYLE BIOPSY NEEDLE | Kormed, Inc. | 1994-10-03 | Traditional | PDF ↗ |
| K941846 | BONE MARROW BIOPSY TRAY | Kormed, Inc. | 1994-05-18 | Traditional | PDF ↗ |
| K925467 | JJ SKINNER CAREKITS(TM) DRY/WET/GEL SKIN SCRUB KIT | J.J. Skinner, Inc. | 1994-05-11 | Traditional | PDF ↗ |
| K934688 | STERILE DESIGN | Sterile Design, Inc. | 1994-03-16 | Traditional | PDF ↗ |
| K935743 | INSTRUMENT TRAY | Cush Medical Products | 1994-03-03 | Traditional | PDF ↗ |
| K936117 | CENTRAL LINE TRAY | Cush Medical Products | 1994-03-01 | Traditional | PDF ↗ |
| K935686 | DRESSING CHANGE TRAY | Cush Medical Products | 1994-02-25 | Traditional | PDF ↗ |
| K935858 | MILL-ROSE PERCUTANEOUS PROCEDURAL KIT | Mill-Rose Laboratory | 1994-02-22 | Traditional | PDF ↗ |
| K935740 | IRRIGATION TRAY | Cush Medical Products | 1994-02-22 | Traditional | PDF ↗ |
| K933137 | ACU-SUTURE KIT | Acuderm, Inc. | 1994-02-22 | Traditional | PDF ↗ |
| K930270 | PATIENT PREOPERATIVE PREP TRAY, SINGLE USE | Professional Medical Products, Inc. | 1994-02-17 | Traditional | PDF ↗ |
| K934028 | STERILE DRESSING CHANGE TRAY | Surgipro, Inc. | 1994-02-17 | Traditional | PDF ↗ |
| K935741 | O.R. BASIN SET TRAY | Cush Medical Products | 1994-02-15 | Traditional | PDF ↗ |
| K935483 | E-Z PREP(R) TRAY WITH HIBICLENS(R) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1994-02-09 | Traditional | PDF ↗ |
| K931820 | CARAPACE STILLWATER BOWL SET | Carapace, Inc. | 1994-02-07 | Traditional | PDF ↗ |
| K934029 | STERILE LACERATION & DEBRIDEMENT TRAYS | Surgipro, Inc. | 1994-02-04 | Traditional | PDF ↗ |
| K931760 | CARAPACE PACKING GAUZE TRAYS | Carapace, Inc. | 1994-02-04 | Traditional | PDF ↗ |
| K934030 | STERILE TRACHEOSTOMY TRAY | Surgipro, Inc. | 1994-01-26 | Traditional | PDF ↗ |
| K920292 | VARIOUS KITS AND TRAYS | Professional Medical Products, Inc. | 1994-01-26 | Traditional | PDF ↗ |
| K931758 | CARAPACE WOUND DRESSING KITS & LACERATION TRAYS | Carapace, Inc. | 1994-01-26 | Traditional | PDF ↗ |
| K931844 | CUSTOM PROCEDURE MEDICAL TRAY OR KIT | Custom Medical Products, Ltd. | 1994-01-25 | Traditional | PDF ↗ |
| K931759 | CARAPACE STERILE GAUZE TRAYS | Carapace, Inc. | 1994-01-25 | Traditional | PDF ↗ |
| K934428 | ARGYLE TURKEL SAFETY PNEUMOTHORAX PROCEDURE TRAY | Sherwood Medical Co. | 1993-12-30 | Traditional | PDF ↗ |
| K931673 | CARAPACE CATARACT TRAYS | Carapace, Inc. | 1993-12-30 | Traditional | PDF ↗ |
| K931824 | CARAPACE INSTRUMLENT AND INSTRUMENT SETS | Carapace, Inc. | 1993-12-06 | Traditional | PDF ↗ |
| K932652 | TRI-MED PARACENTESIS TRAY | Tri-Med Specialties, Inc. | 1993-11-24 | Traditional | PDF ↗ |
| K932217 | MAJOR, MINOR, BASIN TRAYS (PACKS) | Associated Medical Products Co. | 1993-11-15 | Traditional | PDF ↗ |
| K932220 | LAP CHOLY TRAYS (PACKS) | Associated Medical Products Co. | 1993-09-27 | Traditional | PDF ↗ |
| K926269 | PROCEDURE KIT | General Medical Co. | 1993-08-27 | Traditional | PDF ↗ |
| K924468 | STERILE INSTRUMENT TRAYS/BASIN SETS | Baxter Healthcare Corp | 1993-07-09 | Traditional | PDF ↗ |
| K930700 | MEDLINES REPEAT PERFORMANCE SURGICAL PACK SYSTEM | Medline Industries, Inc. | 1993-07-09 | Traditional | PDF ↗ |
| K925214 | SHAVE PREP TRAYS (NON-STERILE) | American Healthcare Supply Co., Inc. | 1993-07-02 | Traditional | PDF ↗ |
| K925216 | STERILE SKIN SCRUB TRAYS | American Healthcare Supply Co., Inc. | 1993-06-22 | Traditional | PDF ↗ |
| K914037 | MEDSURG O.R. PROCEDURE TRAY | Medsurg Industries, Inc. | 1993-06-22 | Traditional | PDF ↗ |
| K922133 | HOSPITAL KIT SV 105 | Savoy Medical Supply Co., Inc. | 1993-06-07 | Traditional | PDF ↗ |
| K925016 | PREP SHAVE KIT (NON-STERILE) | Customed, Inc. | 1993-04-26 | Traditional | PDF ↗ |
| K920267 | DYONICS ARTHROSCOPIC KIT | Smith & Nephew Dyonics, Inc. | 1993-03-23 | Traditional | PDF ↗ |
| K923600 | ENDO OPTIKS VALUE PACK | Endo Optics, Inc. | 1993-03-23 | Traditional | PDF ↗ |
| K922648 | ACE CUSTOM SURGICAL PACK | Ace Surgical Supply Co., Inc. | 1993-03-20 | Traditional | PDF ↗ |
| K914036 | MEDSURG LAPAROSCOPY TRAY | Medsurg Industries, Inc. | 1992-03-18 | Traditional | PDF ↗ |
| K914174 | STERILE DISPOSABLE WET SKIN SCRUB TRAY | Medical Device Inspection Co., Inc. | 1992-02-24 | Traditional | PDF ↗ |
| K914935 | HEART PACK II | Westmark Hospital Supplies | 1992-01-31 | Traditional | PDF ↗ |
| K913136 | LASER ENDOSCOPE DISC DECOMPRESSION KITS | Medical Laser, Inc. | 1991-11-01 | Traditional | PDF ↗ |
| K905459 | SURGICAL PROCEDURE TRAY/LAPAROSCOPY CHOLECYSTECTOM | Angiosystems, Inc. | 1991-04-05 | Traditional | PDF ↗ |
| K910365 | WOUND CLOSURE KIT | Megadyne Medical Products, Inc. | 1991-03-28 | Traditional | PDF ↗ |
| K910368 | MEGA LACERATION KIT | Megadyne Medical Products, Inc. | 1991-03-18 | Traditional | PDF ↗ |
| K905004 | BIO-GUARD O.R. SCRUB PREP TRAY | Network Medical Systems, Inc. | 1991-02-21 | Traditional | PDF ↗ |
| K902887 | CUSTOMED ARTHROSCOPY PACK | Customed, Inc. | 1990-09-10 | Traditional | PDF ↗ |
| K902888 | CUSTOMED ORTHOPEDIC II | Customed, Inc. | 1990-09-10 | Traditional | PDF ↗ |
| K903336 | CUSTOMED HIP PACT | Customed, Inc. | 1990-08-29 | Traditional | PDF ↗ |
| K901856 | CUSTOM WOUND MANAGEMENT KITS AND TRAYS | Medcare Custom Packaging, Inc. | 1990-08-01 | Traditional | PDF ↗ |
| K902293 | ANGIOGRAPHY DRAPE PACK | Biocor Medical, Inc. | 1990-07-19 | Traditional | PDF ↗ |
| K890658 | SYRINGE INJECTION GUN DELIVERY KITS | Gastrotech, Inc. | 1989-10-03 | Traditional | PDF ↗ |
| K895202 | 1420 HEEL-STICK(TM) NEONATAL BLOOD SAMPLING KIT | Transidyne General Corp. | 1989-09-15 | Traditional | PDF ↗ |
| K894685 | DAVIS+GECK VISADUCT KIT | Davis & Geck, Inc. | 1989-08-22 | Traditional | PDF ↗ |
| K893814 | SURGICAL INSTRUMENT KIT, DISPOSABLE | Bioseal | 1989-08-10 | Traditional | PDF ↗ |
| K892389 | BIOPSY KIT | I M, Inc. | 1989-07-17 | Traditional | PDF ↗ |
| K890570 | SKIN SCRUB KIT | Kit Pak, Inc. | 1989-05-05 | Traditional | PDF ↗ |
| K890729 | SUTURE REMOVAL KIT | Cypress Medical Products, Ltd. | 1989-04-17 | Traditional | PDF ↗ |
| K890726 | TRACHEOSTOMY CARE AND CLEANING KITS | Cypress Medical Products, Ltd. | 1989-03-10 | Traditional | PDF ↗ |
| K885090 | HOMER MAMMALOK LOCALIZATION SHIELD | North American Instrument Corp. | 1989-02-14 | Traditional | PDF ↗ |
| K890098 | KLEEN TEST O.R. KIT | Kleen Test Products | 1989-01-24 | Traditional | PDF ↗ |
| K884093 | STERILE DISPOSABLE SURGICAL PACKS | Bolden Surgical Products | 1988-10-19 | Traditional | PDF ↗ |
| K883250 | STERI-CLENS WOUND CARE KIT | Absorbent Cotton Co., Inc. | 1988-08-26 | Traditional | PDF ↗ |
| K882684 | REPAK SURGICAL PACKS - GOWN/TOWEL/MAJOR/DRAPE/BAS. | Standard Textile Co., Inc. | 1988-08-03 | Traditional | PDF ↗ |
| K880961 | ALCON SURGICAL PROCEDURE PACKS | Alcon Laboratories | 1988-04-29 | Traditional | PDF ↗ |
| K881083 | GENERAL PURPOSE KIT | Med-Dex Intl. | 1988-04-07 | Traditional | PDF ↗ |
| K880942 | REPAK SURGICAL PACK (GOWN,TOWEL,MAJOR,DRAPE,BASIC) | Repack Surgical Enterprises, Inc. | 1988-03-21 | Traditional | PDF ↗ |
| K874760 | CK 4900 SERIES, GOWN AND TOWEL PAK | Currie Medical Specialties, Inc. | 1987-12-10 | Traditional | PDF ↗ |
| K873973 | LAKE WOUND CARE/TREATMENT KIT | Lake Medical Products, Inc. | 1987-11-20 | Traditional | PDF ↗ |
| K874439 | SOFT TISSUE ANCHORING SET KIT | Concept, Inc. | 1987-11-20 | Traditional | PDF ↗ |
Product code LRO · Class II · General, Plastic Surgery. Data: openFDA.