FDA Product Code
FDA Product Code KDD — Clearance Directory
- Device Class
- Class I
- Assigned Panel
- General, Plastic Surgery
- 21 CFR Citation
- 878.4800
510(k) Clearances — 62 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K072814 | CONVENIENCE KIT FOR SINGLE-INCISION LAPAROSCOPIC SURGERY AND OTHER ADVANCED LAPAROSCOPIC PROCEDURES | Covidien | 2008-04-16 | Traditional | PDF ↗ |
| K011514 | INSTRUMENTS FOR ONE TIME USE - DISPOSABLE | Kencap , Ltd. | 2001-08-13 | Traditional | PDF ↗ |
| K971317 | NATIONAL MEDICAL HEALTHCARE CUSTOM ORTHOPEDIC KITS AND TRAYS | National Healthcare Mfg. Corp. | 1997-05-08 | Traditional | PDF ↗ |
| K960456 | DENVER PARACENTESIS NEEDLE(60-1200) DENVER PARACENTESIS NEEDLE WITH DRAINAGE LINE(60-1100) DENVER PARACENTESIS TRAY | Denver Biomaterials, Inc. | 1996-04-01 | Traditional | PDF ↗ |
| K936255 | CUSTOM CV PACK | Associated Medical | 1994-03-31 | Traditional | PDF ↗ |
| K932219 | SUTURE SET OR LACERATION TRAYS (PACKS) | Associated Medical Products Co. | 1993-07-09 | Traditional | PDF ↗ |
| K923176 | SURGICAL INSTRUMENT KIT, DISPOSABLE | Ulti-Med Intl., Inc. | 1993-06-17 | Traditional | PDF ↗ |
| K925905 | KIT, SURGICAL INSTRUMENT, DISPOSABLE | Kay Medical Concepts | 1993-06-16 | Traditional | PDF ↗ |
| K924958 | BIOPSY/MYELO/ARTHRO/AMNIOCENT/BASIC SKIN PREP TRAY | Medical Insights, Inc. | 1993-06-07 | Traditional | PDF ↗ |
| K925215 | STERILE SURGICAL INSTRUMENT TRAYS | American Healthcare Supply Co., Inc. | 1993-06-01 | Traditional | PDF ↗ |
| K924117 | DEXIDE LAPAROSCOPIC KITS | Dexide, Inc. | 1993-03-23 | Traditional | PDF ↗ |
| K920989 | SURGICAL INSTRUMENT KIT, DISPOSABLE | Ulti-Med Intl., Inc. | 1992-10-19 | Traditional | PDF ↗ |
| K920763 | LACERATTION TRAY | Sterile Concepts, Inc. | 1992-09-28 | Traditional | PDF ↗ |
| K920516 | GENERAL PURPOSE INSTRUMENT TRAY, STERILE, DISPOSAB | Trinity Laboratories, Inc. | 1992-04-16 | Traditional | PDF ↗ |
| K914244 | STERILE CUSTOM SURGICAL KITS | Ulti-Med Intl., Inc. | 1992-02-24 | Traditional | PDF ↗ |
| K913049 | SLIP-PRUF-CLINGER | Macbrud Corp. Medical Div. | 1991-09-11 | Traditional | PDF ↗ |
| K911606 | BAXTER PREOPERATIVE SKIN PREP TRAY W/FOAM SPONGES | Baxter Healthcare Corp | 1991-07-09 | Traditional | PDF ↗ |
| K910816 | IN-SIGHT SURGICAL INSTRUMENT KITS, DISPOSABLE | Insight International, Inc. | 1991-04-17 | Traditional | PDF ↗ |
| K910369 | INCISION AND DRAINAGE KIT | Megadyne Medical Products, Inc. | 1991-03-28 | Traditional | PDF ↗ |
| K910366 | MEGA GENERAL PURPOSE INSTRUMENT KIT | Megadyne Medical Products, Inc. | 1991-03-28 | Traditional | PDF ↗ |
| K902441 | DISPOSABLE PROCEDURAL TRAYS #CK-XXXXX (VARIOUS) | Currie Medical Specialties, Inc. | 1990-08-23 | Traditional | PDF ↗ |
| K880785 | SKILCRAFT | Pennsylvania Association For the Blind | 1988-03-11 | Traditional | PDF ↗ |
| K874063 | ENTERON ABDOMINAL PARACENTESIS TRAY | Endovations | 1987-12-04 | Traditional | PDF ↗ |
| K871458 | SURVIVAL KIT, INDIVIDUAL, TROP, TACTICAL AIR CREW | Fraass Survival Systems, Inc. | 1987-07-09 | Traditional | PDF ↗ |
| K870373 | STERILE PROCEDURAL TRAYS | Dimed, Intl. | 1987-03-20 | Traditional | PDF ↗ |
| K864969 | JMS HALO APPLICATION TRAY | Jerome Medical | 1987-02-18 | Traditional | PDF ↗ |
| K853910 | SUTURE REMOVAL KIT | Scientific & Medical Care Co. | 1985-10-08 | Traditional | PDF ↗ |
| K843206 | COOK COUNTY HOSPITAL DRESSING CHANGE SET | Geneva Laboratories, Inc. | 1985-05-24 | Traditional | PDF ↗ |
| K850325 | STERILE SUTURE REMOVAL KIT | Excel Health Care Products | 1985-02-26 | Traditional | PDF ↗ |
| K842627 | C-SECTION TRAY | Deroyal Industries, Inc. | 1984-09-26 | Traditional | PDF ↗ |
| K843115 | STERILE SOLUTION BOWL | E.M. Adams | 1984-09-07 | Traditional | PDF ↗ |
| K834135 | STERILE SUTURE BOOTS | Devon Industries, Inc. | 1984-04-27 | Traditional | PDF ↗ |
| K833438 | PREPACELL-STERILE-BONE MARROW ASPIR | Applied Medical Devices, Inc. | 1984-02-09 | Traditional | PDF ↗ |
| K832628 | VYGON THORACIC DRAINAGE-VARIOUS #'S | Exco, Inc. | 1984-01-30 | Traditional | PDF ↗ |
| K833075 | WET DRESSING KIT | Clinipad Corp. | 1984-01-27 | Traditional | PDF ↗ |
| K834532 | STERILE WET DRESSING PACK | W.G. Whitney Corp. | 1984-01-25 | Traditional | PDF ↗ |
| K831841 | STERILE DISP. INSTRUMENT TRAYS | E.M. Adams | 1983-12-14 | Traditional | PDF ↗ |
| K832047 | STERILE SUTURE REMOVAL SET | Ormed Mfg., Inc. | 1983-09-12 | Traditional | PDF ↗ |
| K831795 | FIRST AID KITS | I M, Inc. | 1983-09-01 | Traditional | PDF ↗ |
| K830374 | RESCUE PACK | Akla, Inc. | 1983-05-13 | Traditional | PDF ↗ |
| K822158 | OPEN HEART TRAY (CUSTOM DESIGNED) | Megaplast, Inc. | 1982-10-13 | Traditional | PDF ↗ |
| K821502 | STERILE SUTURE REMOVAL KIT | Pro-Pak | 1982-07-09 | Traditional | PDF ↗ |
| K821814 | HEMO-NATE L-P KIT | Int'L Corp. | 1982-07-09 | Traditional | PDF ↗ |
| K821500 | STERILE CATH CARE KIT | Pro-Pak | 1982-06-23 | Traditional | PDF ↗ |
| K821501 | STERILE TRACHEOSTOMY CARE KIT | Pro-Pak | 1982-06-16 | Traditional | PDF ↗ |
| K820423 | SUTURE REMOVAL TRAY | Megaplast, Inc. | 1982-03-10 | Traditional | PDF ↗ |
| K813103 | ACKRAD INCISION & DRAIN SET | Ackrad Laboratories | 1981-12-09 | Traditional | PDF ↗ |
| K811855 | SKIN SCRUB KITS | Oem Medical Div. | 1981-07-31 | Traditional | PDF ↗ |
| K811086 | SUTURE REMOVAL SET(DISPLSABLE) | Cunningham Woodland, Inc. | 1981-05-01 | Traditional | PDF ↗ |
| K803199 | SUTURE REMOVAL KIT | Walpak Co. | 1981-01-15 | Traditional | PDF ↗ |
| K803119 | LARGE WOUND DRESSING KIT | American Medical Disposable, Inc. | 1980-12-30 | Traditional | PDF ↗ |
| K803117 | CUSTOM DRESSING TRAY WET TO DRY | American Medical Disposable, Inc. | 1980-12-23 | Traditional | PDF ↗ |
| K803118 | SIMPLE DRESSING TRAY #82028 | American Medical Disposable, Inc. | 1980-12-22 | Traditional | PDF ↗ |
| K802557 | EMERGENCY DEPARTMENT LACERATION KIT- | Johnson & Johnson Professionals, Inc. | 1980-11-12 | Traditional | PDF ↗ |
| K802017 | DRESSING CHANGE SET CAT.#910-930 | Pollak (Intl.), Ltd. | 1980-10-10 | Traditional | PDF ↗ |
| K802019 | SUTURE REMOVAL SET CAT.#906 | Pollak (Intl.), Ltd. | 1980-09-16 | Traditional | PDF ↗ |
| K780488 | INSTRUMENT AND ACCESSORY KIT | American Hospital Supply Corp. | 1978-04-12 | Traditional | PDF ↗ |
| K780336 | URINE SAMPLE KIT | American Hospital Supply Corp. | 1978-04-03 | Traditional | PDF ↗ |
| K771448 | STERILE SUTURE REMOVAL KIT | Premium Plastics, Inc. | 1977-09-06 | Traditional | PDF ↗ |
| K770149 | MAJOR SUTURE REMOVAL TRAY | Pharmaseal Div., Baxter Healthcare Corp. | 1977-02-25 | Traditional | PDF ↗ |
| K761193 | SUTURE REMOVAL KIT | Superior Plastic Products Corp. | 1977-01-12 | Traditional | PDF ↗ |
| K760051 | TRAY, SUTURE REMOVAL | M-C Ind., Inc. | 1976-08-30 | Traditional | PDF ↗ |
Product code KDD · Class I · General, Plastic Surgery. Data: openFDA.