FDA Product Code
FDA Product Code FSM — Clearance Directory
- Device Class
- Class I
- Assigned Panel
- General, Plastic Surgery
- 21 CFR Citation
- 878.4800
510(k) Clearances — 76 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K971217 | INSTRUMENT TRAY LINER | General Hospital Supply Corp. | 1997-05-06 | Traditional | PDF ↗ |
| K962328 | SINGLE USE INSTRUMENT TRAY | Medcare Medical Group, Inc. | 1996-08-09 | Traditional | PDF ↗ |
| K944025 | SURGICAL INSTRUMENT TRAY | Riley Medical, Inc. | 1994-11-22 | Traditional | PDF ↗ |
| K912106 | ARTHROSCOPY TRAY | Medical Device Inspection Co., Inc. | 1991-08-29 | Traditional | PDF ↗ |
| K912053 | OPEN HEART TRAY | Medical Device Inspection Co., Inc. | 1991-08-26 | Traditional | PDF ↗ |
| K912052 | HEART CATH TRAY | Medical Device Inspection Co., Inc. | 1991-08-20 | Traditional | PDF ↗ |
| K912104 | MAJOR BASIN TRAY | Medical Device Inspection Co., Inc. | 1991-08-09 | Traditional | PDF ↗ |
| K910570 | SPLINTER TWEEZERS | Solan Scissors Sales | 1991-05-31 | Traditional | PDF ↗ |
| K911601 | REDDICK TROCAR AND CANNULA | Ideal Medical, Inc. | 1991-05-21 | Traditional | PDF ↗ |
| K910328 | KEY COMFORT GRIPS | Key Surgical, Inc. | 1991-03-06 | Traditional | PDF ↗ |
| K905682 | RICHARD-ALLAN CLAMP COVERS | Richard-Allan Medical | 1991-02-19 | Traditional | PDF ↗ |
| K900376 | HAND SURGERY AND IRRIGATION TRAY (MODEL 3625) | Pmt Corp. | 1990-04-10 | Traditional | PDF ↗ |
| K894610 | CUSTOM TRAYS, KITS | L H M Ent., Inc. | 1990-03-15 | Traditional | PDF ↗ |
| K900479 | STERILE LACERATION TRAY CAT. #749 | Busse Hospital Disposables, Inc. | 1990-02-13 | Traditional | PDF ↗ |
| K895527 | THE NEEDLE COUNT AND SHARPS DISPOSAL SYSTEM | Quantitative Technologies, Inc. | 1989-10-06 | Traditional | PDF ↗ |
| K883193 | CASF STERILIZATION TRAY | Terray Manufacturing, Inc. | 1988-08-10 | Traditional | PDF ↗ |
| K883125 | CASF STERILIZATION TRAY | Terray Manufacturing, Inc. | 1988-08-10 | Traditional | PDF ↗ |
| K882617 | BREVET CASSETTE STERILIZATION MODULE | Brevet, Inc. | 1988-07-28 | Traditional | PDF ↗ |
| K871924 | STERILIZATION TRAY, TMJ INSTRUMENT SET | Arthropedics, Inc. | 1987-06-01 | Traditional | PDF ↗ |
| K871478 | SURGICAL PACKS, SURGICAL KITS AND SURGICAL TRAYS | Procedure Pak, Inc. | 1987-05-07 | Traditional | PDF ↗ |
| K870892 | MEDSURG PERCUTANEOUS ASPIRATION BIOPSY (PAB) TRAY | Medsurg Industries, Inc. | 1987-04-10 | Traditional | PDF ↗ |
| K870417 | RCT-1, RCT-2, RCT-3 ARTHROGRAM TRAY | North Coast Medi-Tek | 1987-03-05 | Traditional | PDF ↗ |
| K864920 | SCANLAN (TM) INSTRUMENT TRAY | Scanlan Intl., Inc. | 1987-01-12 | Traditional | PDF ↗ |
| K863726 | INSTRUMENT STERILIZATION TRAY | Medical Technology Development Corp. | 1986-10-14 | Traditional | PDF ↗ |
| K862629 | SURGICAL LASER ACCESSORIES (SLA) CASE | Simpson/Basye, Inc. | 1986-07-17 | Traditional | PDF ↗ |
| K862154 | VENESECTION EQUIPMENT STORAGE TRAY | Rmp Co. | 1986-06-16 | Traditional | PDF ↗ |
| K861530 | SURGICAL PACKS, KITS AND TRAYS | Medical Concepts Development, Inc. | 1986-05-30 | Traditional | PDF ↗ |
| K861525 | DISPOSABLE SURG KITS/GOWNS/GUARDS/COVERS/MASKS | D & D Products, Inc. | 1986-05-06 | Traditional | PDF ↗ |
| K860160 | OPERATING ROOM TRAY | Medical Design Concepts, Inc. | 1986-02-27 | Traditional | PDF ↗ |
| K854746 | SURGICAL INSTRUMENT TRAY | Zbi, Inc. | 1985-12-17 | Traditional | PDF ↗ |
| K844613 | GENERAL PURPOSE INSTRUMENT TRAYS SUTURE REMOVAL TR | Packaging Technologies, Inc. | 1985-01-10 | Traditional | PDF ↗ |
| K844652 | C.A.S.E. CONTAINER | General Medical Co. | 1984-12-12 | Traditional | PDF ↗ |
| K843627 | VENESECTION TRAY, ADULT 6050 | Pro-Lab, Inc. | 1984-12-04 | Traditional | PDF ↗ |
| K844286 | FLASH GUARD PLASTIC VERSION | Sparco, Inc. | 1984-11-19 | Traditional | PDF ↗ |
| K844002 | HU-FRIEDY IMS CASSETTE SYSTEM | Hu-Friedy Mfg. Co., Inc. | 1984-11-08 | Traditional | PDF ↗ |
| K843564 | MSI SURGI-GRADE SUTURE TRAY | Medical Sterilization, Inc. | 1984-10-31 | Traditional | PDF ↗ |
| K843561 | MSI SURGI-GRADE UNIVERSAL TRACH TRAY | Medical Sterilization, Inc. | 1984-10-24 | Traditional | PDF ↗ |
| K842009 | ABDOMINAL PARACENTESIS TRAY | Jayco Pharmaceuticals | 1984-10-23 | Traditional | PDF ↗ |
| K843563 | MSI SURGI-GRADE INCISION & DRAIN TRAY | Medical Sterilization, Inc. | 1984-10-23 | Traditional | PDF ↗ |
| K843723 | STERILE INSTRUMENT TRAYS-VARIOUS | E.M. Adams | 1984-10-23 | Traditional | PDF ↗ |
| K840976 | VARIOUS DISPOSABLE KITS/TRAYS/INSTRU | Carapace, Inc. | 1984-05-31 | Traditional | PDF ↗ |
| K841122 | TRACHEOSTOMY CARE TRAY | Medcare Products | 1984-04-25 | Traditional | PDF ↗ |
| K840021 | OPERATING ROOM TRAY SET | Medi-Plast Intl., Inc. | 1984-03-15 | Traditional | PDF ↗ |
| K833058 | GEN. PURPOSE INSTRUMENT TRAYS & | Inter-Med Corp. | 1984-01-31 | Traditional | PDF ↗ |
| K832137 | CONVERTORS FLASH STERILIZING TRAY | American Convertors Div., American Pharmaseal | 1983-08-12 | Traditional | PDF ↗ |
| K830219 | VARIOUS INSTRUMENTS & INSTRUMENT TRAYS | Ascep, Inc. | 1983-04-12 | Traditional | PDF ↗ |
| K823854 | MEDCARE SUTURE REMOVAL TRAYS | Medcare Products | 1983-03-31 | Traditional | PDF ↗ |
| K823853 | MEDCARE WOUND CLOSURE TRAY | Medcare Products | 1983-01-14 | Traditional | PDF ↗ |
| K823438 | HANDI-TRAY | Treace Medical, Inc. | 1983-01-14 | Traditional | PDF ↗ |
| K823855 | MEDCARE INCISION & DRAINAGE TRAY | Medcare Products | 1983-01-14 | Traditional | PDF ↗ |
| K823856 | MEDCARE GENERAL PURPOSE TRAY | Medcare Products | 1983-01-14 | Traditional | PDF ↗ |
| K823430 | INSTRA-SAFE | Instranetics, Inc. | 1983-01-07 | Traditional | PDF ↗ |
| K820332 | NEEDLE & BLADE COUNTER | Abco Dist. | 1982-02-23 | Traditional | PDF ↗ |
| K812134 | INCISION & DRAINAGE TRAY | E.M. Adams | 1982-01-15 | Traditional | PDF ↗ |
| K812133 | WOUND CLOSURE INSTRUMENT TRAY | E.M. Adams | 1982-01-08 | Traditional | PDF ↗ |
| K811916 | OPERATING ROOM KIT | American Hospital Supply Corp. | 1981-10-14 | Traditional | PDF ↗ |
| K811087 | MIKA SKIN SCRUB TRAY PRE OPERATIVE W/GEL | Cunningham Woodland, Inc. | 1981-05-01 | Traditional | PDF ↗ |
| K810004 | STERILE DISPOSABLE INSTRUMENT TRAYS | Ascep, Inc. | 1981-01-26 | Traditional | PDF ↗ |
| K802965 | AMPCO-DRESSING CHANGE TRAY-MAJOR DC 7418 | Associated Medical Products Co. | 1981-01-05 | Traditional | PDF ↗ |
| K802964 | AMPCO-DRESSING CHANGE TRAY-MAJOR DC | Associated Medical Products Co. | 1981-01-05 | Traditional | PDF ↗ |
| K802088 | AUXILIARY TRAY | American Pharmaseal Div. Ahsc | 1980-11-28 | Traditional | PDF ↗ |
| K802570 | A.M.P.C.O. SKIN SCRUB TRAY | Associated Medical Products Co. | 1980-11-14 | Traditional | PDF ↗ |
| K801964 | CUSTOM LYMPHANGIOGRAM ACCES. PACK-STERI | American Pharmaseal Div. Ahsc | 1980-10-10 | Traditional | PDF ↗ |
| K801965 | CUSTOM UNIVERSAL CUTDOWN PREP TRAY | American Pharmaseal Div. Ahsc | 1980-10-10 | Traditional | PDF ↗ |
| K801470 | MICRO CLIP STERILIZING CASE #65199 | Edward Weck, Inc. | 1980-07-14 | Traditional | PDF ↗ |
| K800418 | ADT DISPOSABLE THIN NEEDLE ASPIRATION | A.D.T. Lab Industries | 1980-04-28 | Traditional | PDF ↗ |
| K800367 | MICRESURGICAL TRAY, SM.,MED., & LG. | Edward Weck, Inc. | 1980-03-10 | Traditional | PDF ↗ |
| K791889 | SUTURE REMOVAL TRAY, REORDER 7950&7951 | Ascep, Inc. | 1979-10-17 | Traditional | PDF ↗ |
| K791887 | CENTRAL VENOUS CATHETER DRESSING TRAY | Ascep, Inc. | 1979-10-17 | Traditional | PDF ↗ |
| K791743 | WECK RACK (STERILIZING ACCESSORY TRAY) | Edward Weck, Inc. | 1979-09-26 | Traditional | PDF ↗ |
| K770428 | VARIOUS SURG. & DIAGNOSTIC INSTRU. ETC. | Holco Instrument Corp. | 1979-09-12 | Traditional | PDF ↗ |
| K772266 | INSTRUMENT TRAY | Med Fusion Systems, Inc. | 1978-01-20 | Traditional | PDF ↗ |
| K771680 | ARMOR-KOT SURGICAL INSTRUMENTS | Storz Instrument Co. | 1977-11-28 | Traditional | PDF ↗ |
| K760579 | INSTRUMENT RACK FOR DAWSON-YUHL INSTR. | V. Mueller O.V. Baxter Healthcare Corp. | 1976-11-02 | Traditional | PDF ↗ |
| K760428 | SUTURE RACK & NEEDLE COUNTER | Kleen Test Products | 1976-11-02 | Traditional | PDF ↗ |
| K760311 | INSTRUMENTS, GENERAL HAND & SURGERY | Depuy, Inc. | 1976-08-09 | Traditional | PDF ↗ |
Product code FSM · Class I · General, Plastic Surgery. Data: openFDA.