FSM · Tray, Surgical, Instrument
General, Plastic Surgery · 21 CFR 878.4800 · Class 1
Overview
| Product Code | FSM |
|---|---|
| Device Name | Tray, Surgical, Instrument |
| Regulation | 21 CFR 878.4800 |
| Device Class | Class 1 |
| Review Panel | General, Plastic Surgery |
Identification
A manual surgical instrument for general use is a nonpowered, hand-held, or hand manipulated device, either reusable or disposable, intended to be used in various general surgical procedures. The device includes the applicator, clip applier, biopsy brush, manual dermabrasion brush, scrub brush, cannula, ligature carrier, chisel, clamp, contractor, curette, cutter, dissector, elevator, skin graft expander, file, forceps, gouge, instrument guide, needle guide, hammer, hemostat, amputation hook, ligature passing and knot-tying instrument, knife, mallet, disposable or reusable aspiration and injection needle, disposable or reusable suturing needle, osteotome, pliers, rasp, retainer, retractor, saw, scalpel blade, scalpel handle, one-piece scalpel, snare, spatula, stapler, disposable or reusable stripper, stylet, suturing apparatus for the stomach and intestine, measuring tape, and calipers. A surgical instrument that has specialized uses in a specific medical specialty is classified in separate regulations in parts 868 through 892 of this chapter.
Classification Rationale
Class I (general controls). The device 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 (76)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K971217 | INSTRUMENT TRAY LINER | General Hospital Supply Corp. | May 6, 1997 | SESE |
| K962328 | SINGLE USE INSTRUMENT TRAY | Medcare Medical Group, Inc. | Aug 9, 1996 | SESE |
| K944025 | SURGICAL INSTRUMENT TRAY | Riley Medical, Inc. | Nov 22, 1994 | SESE |
| K912106 | ARTHROSCOPY TRAY | Medical Device Inspection Co., Inc. | Aug 29, 1991 | SESE |
| K912053 | OPEN HEART TRAY | Medical Device Inspection Co., Inc. | Aug 26, 1991 | SESE |
| K912052 | HEART CATH TRAY | Medical Device Inspection Co., Inc. | Aug 20, 1991 | SESE |
| K912104 | MAJOR BASIN TRAY | Medical Device Inspection Co., Inc. | Aug 9, 1991 | SESE |
| K910570 | SPLINTER TWEEZERS | Solan Scissors Sales | May 31, 1991 | SESE |
| K911601 | REDDICK TROCAR AND CANNULA | Ideal Medical, Inc. | May 21, 1991 | SESE |
| K910328 | KEY COMFORT GRIPS | Key Surgical, Inc. | Mar 6, 1991 | SESE |
| K905682 | RICHARD-ALLAN CLAMP COVERS | Richard-Allan Medical | Feb 19, 1991 | SESE |
| K900376 | HAND SURGERY AND IRRIGATION TRAY (MODEL 3625) | Pmt Corp. | Apr 10, 1990 | SESE |
| K894610 | CUSTOM TRAYS, KITS | L H M Ent., Inc. | Mar 15, 1990 | SESD |
| K900479 | STERILE LACERATION TRAY CAT. #749 | Busse Hospital Disposables, Inc. | Feb 13, 1990 | SESE |
| K895527 | THE NEEDLE COUNT AND SHARPS DISPOSAL SYSTEM | Quantitative Technologies, Inc. | Oct 6, 1989 | SESE |
| K883193 | CASF STERILIZATION TRAY | Terray Manufacturing, Inc. | Aug 10, 1988 | SESE |
| K883125 | CASF STERILIZATION TRAY | Terray Manufacturing, Inc. | Aug 10, 1988 | SESE |
| K882617 | BREVET CASSETTE STERILIZATION MODULE | Brevet, Inc. | Jul 28, 1988 | SESE |
| K871924 | STERILIZATION TRAY, TMJ INSTRUMENT SET | Arthropedics, Inc. | Jun 1, 1987 | SESE |
| K871478 | SURGICAL PACKS, SURGICAL KITS AND SURGICAL TRAYS | Procedure Pak, Inc. | May 7, 1987 | SESE |
| K870892 | MEDSURG PERCUTANEOUS ASPIRATION BIOPSY (PAB) TRAY | Medsurg Industries, Inc. | Apr 10, 1987 | SESD |
| K870417 | RCT-1, RCT-2, RCT-3 ARTHROGRAM TRAY | North Coast Medi-Tek | Mar 5, 1987 | SESE |
| K864920 | SCANLAN (TM) INSTRUMENT TRAY | Scanlan Intl., Inc. | Jan 12, 1987 | SESE |
| K863726 | INSTRUMENT STERILIZATION TRAY | Medical Technology Development Corp. | Oct 14, 1986 | SESE |
| K862629 | SURGICAL LASER ACCESSORIES (SLA) CASE | Simpson/Basye, Inc. | Jul 17, 1986 | SESE |
| K862154 | VENESECTION EQUIPMENT STORAGE TRAY | Rmp Co. | Jun 16, 1986 | SESE |
| K861530 | SURGICAL PACKS, KITS AND TRAYS | Medical Concepts Development, Inc. | May 30, 1986 | SESD |
| K861525 | DISPOSABLE SURG KITS/GOWNS/GUARDS/COVERS/MASKS | D & D Products, Inc. | May 6, 1986 | SESE |
| K860160 | OPERATING ROOM TRAY | Medical Design Concepts, Inc. | Feb 27, 1986 | SESE |
| K854746 | SURGICAL INSTRUMENT TRAY | Zbi, Inc. | Dec 17, 1985 | SESE |
| K844613 | GENERAL PURPOSE INSTRUMENT TRAYS SUTURE REMOVAL TR | Packaging Technologies, Inc. | Jan 10, 1985 | SESE |
| K844652 | C.A.S.E. CONTAINER | General Medical Co. | Dec 12, 1984 | SESE |
| K843627 | VENESECTION TRAY, ADULT 6050 | Pro-Lab, Inc. | Dec 4, 1984 | SESE |
| K844286 | FLASH GUARD PLASTIC VERSION | Sparco, Inc. | Nov 19, 1984 | SESE |
| K844002 | HU-FRIEDY IMS CASSETTE SYSTEM | Hu-Friedy Mfg. Co., Inc. | Nov 8, 1984 | SESE |
| K843564 | MSI SURGI-GRADE SUTURE TRAY | Medical Sterilization, Inc. | Oct 31, 1984 | SESE |
| K843561 | MSI SURGI-GRADE UNIVERSAL TRACH TRAY | Medical Sterilization, Inc. | Oct 24, 1984 | SESE |
| K843723 | STERILE INSTRUMENT TRAYS-VARIOUS | E.M. Adams | Oct 23, 1984 | SESE |
| K843563 | MSI SURGI-GRADE INCISION & DRAIN TRAY | Medical Sterilization, Inc. | Oct 23, 1984 | SESE |
| K842009 | ABDOMINAL PARACENTESIS TRAY | Jayco Pharmaceuticals | Oct 23, 1984 | SESE |
| K840976 | VARIOUS DISPOSABLE KITS/TRAYS/INSTRU | Carapace, Inc. | May 31, 1984 | SESE |
| K841122 | TRACHEOSTOMY CARE TRAY | Medcare Products | Apr 25, 1984 | SESE |
| K840021 | OPERATING ROOM TRAY SET | Medi-Plast Intl., Inc. | Mar 15, 1984 | SESE |
| K833058 | GEN. PURPOSE INSTRUMENT TRAYS & | Inter-Med Corp. | Jan 31, 1984 | SESE |
| K832137 | CONVERTORS FLASH STERILIZING TRAY | American Convertors Div., American Pharmaseal | Aug 12, 1983 | SESE |
| K830219 | VARIOUS INSTRUMENTS & INSTRUMENT TRAYS | Ascep, Inc. | Apr 12, 1983 | SESE |
| K823854 | MEDCARE SUTURE REMOVAL TRAYS | Medcare Products | Mar 31, 1983 | SESE |
| K823856 | MEDCARE GENERAL PURPOSE TRAY | Medcare Products | Jan 14, 1983 | SESE |
| K823855 | MEDCARE INCISION & DRAINAGE TRAY | Medcare Products | Jan 14, 1983 | SESE |
| K823853 | MEDCARE WOUND CLOSURE TRAY | Medcare Products | Jan 14, 1983 | SESE |
| K823438 | HANDI-TRAY | Treace Medical, Inc. | Jan 14, 1983 | SESE |
| K823430 | INSTRA-SAFE | Instranetics, Inc. | Jan 7, 1983 | SESE |
| K820332 | NEEDLE & BLADE COUNTER | Abco Dist. | Feb 23, 1982 | SESE |
| K812134 | INCISION & DRAINAGE TRAY | E.M. Adams | Jan 15, 1982 | SESE |
| K812133 | WOUND CLOSURE INSTRUMENT TRAY | E.M. Adams | Jan 8, 1982 | SESE |
| K811916 | OPERATING ROOM KIT | American Hospital Supply Corp. | Oct 14, 1981 | SESE |
| K811087 | MIKA SKIN SCRUB TRAY PRE OPERATIVE W/GEL | Cunningham Woodland, Inc. | May 1, 1981 | SESE |
| K810004 | STERILE DISPOSABLE INSTRUMENT TRAYS | Ascep, Inc. | Jan 26, 1981 | SESE |
| K802965 | AMPCO-DRESSING CHANGE TRAY-MAJOR DC 7418 | Associated Medical Products Co. | Jan 5, 1981 | SESE |
| K802964 | AMPCO-DRESSING CHANGE TRAY-MAJOR DC | Associated Medical Products Co. | Jan 5, 1981 | SESE |
| K802088 | AUXILIARY TRAY | American Pharmaseal Div. Ahsc | Nov 28, 1980 | SESE |
| K802570 | A.M.P.C.O. SKIN SCRUB TRAY | Associated Medical Products Co. | Nov 14, 1980 | SESE |
| K801965 | CUSTOM UNIVERSAL CUTDOWN PREP TRAY | American Pharmaseal Div. Ahsc | Oct 10, 1980 | SESE |
| K801964 | CUSTOM LYMPHANGIOGRAM ACCES. PACK-STERI | American Pharmaseal Div. Ahsc | Oct 10, 1980 | SESE |
| K801470 | MICRO CLIP STERILIZING CASE #65199 | Edward Weck, Inc. | Jul 14, 1980 | SESE |
| K800418 | ADT DISPOSABLE THIN NEEDLE ASPIRATION | A.D.T. Lab Industries | Apr 28, 1980 | SESE |
| K800367 | MICRESURGICAL TRAY, SM.,MED., & LG. | Edward Weck, Inc. | Mar 10, 1980 | SESE |
| K791889 | SUTURE REMOVAL TRAY, REORDER 7950&7951 | Ascep, Inc. | Oct 17, 1979 | SESE |
| K791887 | CENTRAL VENOUS CATHETER DRESSING TRAY | Ascep, Inc. | Oct 17, 1979 | SESE |
| K791743 | WECK RACK (STERILIZING ACCESSORY TRAY) | Edward Weck, Inc. | Sep 26, 1979 | SESE |
| K770428 | VARIOUS SURG. & DIAGNOSTIC INSTRU. ETC. | Holco Instrument Corp. | Sep 12, 1979 | SESE |
| K772266 | INSTRUMENT TRAY | Med Fusion Systems, Inc. | Jan 20, 1978 | SESE |
| K771680 | ARMOR-KOT SURGICAL INSTRUMENTS | Storz Instrument Co. | Nov 28, 1977 | SESE |
| K760579 | INSTRUMENT RACK FOR DAWSON-YUHL INSTR. | V. Mueller O.V. Baxter Healthcare Corp. | Nov 2, 1976 | SESE |
| K760428 | SUTURE RACK & NEEDLE COUNTER | Kleen Test Products | Nov 2, 1976 | SESE |
| K760311 | INSTRUMENTS, GENERAL HAND & SURGERY | Depuy, Inc. | Aug 9, 1976 | SESE |
Top Applicants
- Medcare Products — 5 clearances
- Medical Device Inspection Co., Inc. — 4 clearances
- Ascep, Inc. — 4 clearances
- Medical Sterilization, Inc. — 3 clearances
- Edward Weck, Inc. — 3 clearances
