Product Code: FSM
FDA class 1
21 CFR 878.4800
Tray, Surgical, Instrument
General, Plastic Surgery
A surgical instrument tray is a container used in the operating room to hold and organize surgical instruments during and between procedures, maintaining order and sterility. It is classified as FDA Class 1 (lowest risk), subject to general controls only, and does not require premarket notification. The product code is FSM, regulated under 21 CFR 878.4800, within the General, Plastic Surgery medical specialty. No special flags apply to this device.
510(k)s
76
FEI Numbers
880
Registration Numbers
880
Unique Applicants
55
Years Active
21
Basic Information
- Product Code
- FSM
- Device Class
- FDA class 1
- Regulation Number
- 878.4800
- Medical Specialty
- General, Plastic Surgery
- Review Panel
- SU
- Submission Type
- 4
Device Characteristics
✗
GMP Exempt
✗
Implant
✗
Life Sustain/Support
✗
Third Party
—
Summary Malfunction Reporting
510(k) Clearance History
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Related 510(k) Clearances
This FDA classification is associated with 76 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K971217 | INSTRUMENT TRAY LINER | May 06, 1997 | Substantially Equivalent | GENERAL HOSPITAL SUPPLY CORP. |
| K962328 | SINGLE USE INSTRUMENT TRAY | Aug 09, 1996 | Substantially Equivalent | MEDCARE MEDICAL GROUP, INC. |
| K944025 | SURGICAL INSTRUMENT TRAY | Nov 22, 1994 | Substantially Equivalent | RILEY MEDICAL, INC. |
| K912106 | ARTHROSCOPY TRAY | Aug 29, 1991 | Substantially Equivalent | MEDICAL DEVICE INSPECTION CO., INC. |
| K912053 | OPEN HEART TRAY | Aug 26, 1991 | Substantially Equivalent | MEDICAL DEVICE INSPECTION CO., INC. |
| K912052 | HEART CATH TRAY | Aug 20, 1991 | Substantially Equivalent | MEDICAL DEVICE INSPECTION CO., INC. |
| K912104 | MAJOR BASIN TRAY | Aug 09, 1991 | Substantially Equivalent | MEDICAL DEVICE INSPECTION CO., INC. |
| K910570 | SPLINTER TWEEZERS | May 31, 1991 | Substantially Equivalent | SOLAN SCISSORS SALES |
| K911601 | REDDICK TROCAR AND CANNULA | May 21, 1991 | Substantially Equivalent | IDEAL MEDICAL, INC. |
| K910328 | KEY COMFORT GRIPS | Mar 06, 1991 | Substantially Equivalent | KEY SURGICAL, INC. |
| K905682 | RICHARD-ALLAN CLAMP COVERS | Feb 19, 1991 | Substantially Equivalent | RICHARD-ALLAN MEDICAL |
| K900376 | HAND SURGERY AND IRRIGATION TRAY (MODEL 3625) | Apr 10, 1990 | Substantially Equivalent | PMT CORP. |
| K894610 | CUSTOM TRAYS, KITS | Mar 15, 1990 | Unknown | L H M ENT., INC. |
| K900479 | STERILE LACERATION TRAY CAT. #749 | Feb 13, 1990 | Substantially Equivalent | BUSSE HOSPITAL DISPOSABLES, INC. |
| K895527 | THE NEEDLE COUNT AND SHARPS DISPOSAL SYSTEM | Oct 06, 1989 | Substantially Equivalent | QUANTITATIVE TECHNOLOGIES, INC. |
| K883193 | CASF STERILIZATION TRAY | Aug 10, 1988 | Substantially Equivalent | TERRAY MANUFACTURING, INC. |
| K883125 | CASF STERILIZATION TRAY | Aug 10, 1988 | Substantially Equivalent | TERRAY MANUFACTURING, INC. |
| K882617 | BREVET CASSETTE STERILIZATION MODULE | Jul 28, 1988 | Substantially Equivalent | BREVET, INC. |
| K871924 | STERILIZATION TRAY, TMJ INSTRUMENT SET | Jun 01, 1987 | Substantially Equivalent | ARTHROPEDICS, INC. |
| K871478 | SURGICAL PACKS, SURGICAL KITS AND SURGICAL TRAYS | May 07, 1987 | Substantially Equivalent | PROCEDURE PAK, INC. |
| K870892 | MEDSURG PERCUTANEOUS ASPIRATION BIOPSY (PAB) TRAY | Apr 10, 1987 | Unknown | MEDSURG INDUSTRIES, INC. |
| K870417 | RCT-1, RCT-2, RCT-3 ARTHROGRAM TRAY | Mar 05, 1987 | Substantially Equivalent | NORTH COAST MEDI-TEK |
| K864920 | SCANLAN (TM) INSTRUMENT TRAY | Jan 12, 1987 | Substantially Equivalent | SCANLAN INTL., INC. |
| K863726 | INSTRUMENT STERILIZATION TRAY | Oct 14, 1986 | Substantially Equivalent | MEDICAL TECHNOLOGY DEVELOPMENT CORP. |
| K862629 | SURGICAL LASER ACCESSORIES (SLA) CASE | Jul 17, 1986 | Substantially Equivalent | SIMPSON/BASYE, INC. |
| K862154 | VENESECTION EQUIPMENT STORAGE TRAY | Jun 16, 1986 | Substantially Equivalent | RMP CO. |
| K861530 | SURGICAL PACKS, KITS AND TRAYS | May 30, 1986 | Unknown | MEDICAL CONCEPTS DEVELOPMENT, INC. |
| K861525 | DISPOSABLE SURG KITS/GOWNS/GUARDS/COVERS/MASKS | May 06, 1986 | Substantially Equivalent | D & D PRODUCTS, INC. |
| K860160 | OPERATING ROOM TRAY | Feb 27, 1986 | Substantially Equivalent | MEDICAL DESIGN CONCEPTS, INC. |
| K854746 | SURGICAL INSTRUMENT TRAY | Dec 17, 1985 | Substantially Equivalent | ZBI, INC. |
| K844613 | GENERAL PURPOSE INSTRUMENT TRAYS SUTURE REMOVAL TR | Jan 10, 1985 | Substantially Equivalent | PACKAGING TECHNOLOGIES, INC. |
| K844652 | C.A.S.E. CONTAINER | Dec 12, 1984 | Substantially Equivalent | GENERAL MEDICAL CO. |
| K843627 | VENESECTION TRAY, ADULT 6050 | Dec 04, 1984 | Substantially Equivalent | PRO-LAB, INC. |
| K844286 | FLASH GUARD PLASTIC VERSION | Nov 19, 1984 | Substantially Equivalent | SPARCO, INC. |
| K844002 | HU-FRIEDY IMS CASSETTE SYSTEM | Nov 08, 1984 | Substantially Equivalent | HU-FRIEDY MFG. CO.,INC. |
| K843564 | MSI SURGI-GRADE SUTURE TRAY | Oct 31, 1984 | Substantially Equivalent | MEDICAL STERILIZATION, INC. |
| K843561 | MSI SURGI-GRADE UNIVERSAL TRACH TRAY | Oct 24, 1984 | Substantially Equivalent | MEDICAL STERILIZATION, INC. |
| K843723 | STERILE INSTRUMENT TRAYS-VARIOUS | Oct 23, 1984 | Substantially Equivalent | E.M. ADAMS |
| K843563 | MSI SURGI-GRADE INCISION & DRAIN TRAY | Oct 23, 1984 | Substantially Equivalent | MEDICAL STERILIZATION, INC. |
| K842009 | ABDOMINAL PARACENTESIS TRAY | Oct 23, 1984 | Substantially Equivalent | JAYCO PHARMACEUTICALS |
| K840976 | VARIOUS DISPOSABLE KITS/TRAYS/INSTRU | May 31, 1984 | Substantially Equivalent | CARAPACE, INC. |
| K841122 | TRACHEOSTOMY CARE TRAY | Apr 25, 1984 | Substantially Equivalent | MEDCARE PRODUCTS |
| K840021 | OPERATING ROOM TRAY SET | Mar 15, 1984 | Substantially Equivalent | MEDI-PLAST INTL., INC. |
| K833058 | GEN. PURPOSE INSTRUMENT TRAYS & | Jan 31, 1984 | Substantially Equivalent | INTER-MED CORP. |
| K832137 | CONVERTORS FLASH STERILIZING TRAY | Aug 12, 1983 | Substantially Equivalent | AMERICAN CONVERTORS DIV., AMERICAN PHARMASEAL |
| K830219 | VARIOUS INSTRUMENTS & INSTRUMENT TRAYS | Apr 12, 1983 | Substantially Equivalent | ASCEP, INC. |
| K823854 | MEDCARE SUTURE REMOVAL TRAYS | Mar 31, 1983 | Substantially Equivalent | MEDCARE PRODUCTS |
| K823856 | MEDCARE GENERAL PURPOSE TRAY | Jan 14, 1983 | Substantially Equivalent | MEDCARE PRODUCTS |
| K823855 | MEDCARE INCISION & DRAINAGE TRAY | Jan 14, 1983 | Substantially Equivalent | MEDCARE PRODUCTS |
| K823853 | MEDCARE WOUND CLOSURE TRAY | Jan 14, 1983 | Substantially Equivalent | MEDCARE PRODUCTS |
| K823438 | HANDI-TRAY | Jan 14, 1983 | Substantially Equivalent | TREACE MEDICAL, INC. |
| K823430 | INSTRA-SAFE | Jan 07, 1983 | Substantially Equivalent | INSTRANETICS, INC. |
| K820332 | NEEDLE & BLADE COUNTER | Feb 23, 1982 | Substantially Equivalent | ABCO DIST. |
| K812134 | INCISION & DRAINAGE TRAY | Jan 15, 1982 | Substantially Equivalent | E.M. ADAMS |
| K812133 | WOUND CLOSURE INSTRUMENT TRAY | Jan 08, 1982 | Substantially Equivalent | E.M. ADAMS |
| K811916 | OPERATING ROOM KIT | Oct 14, 1981 | Substantially Equivalent | AMERICAN HOSPITAL SUPPLY CORP. |
| K811087 | MIKA SKIN SCRUB TRAY PRE OPERATIVE W/GEL | May 01, 1981 | Substantially Equivalent | CUNNINGHAM WOODLAND, INC. |
| K810004 | STERILE DISPOSABLE INSTRUMENT TRAYS | Jan 26, 1981 | Substantially Equivalent | ASCEP, INC. |
| K802965 | AMPCO-DRESSING CHANGE TRAY-MAJOR DC 7418 | Jan 05, 1981 | Substantially Equivalent | ASSOCIATED MEDICAL PRODUCTS CO. |
| K802964 | AMPCO-DRESSING CHANGE TRAY-MAJOR DC | Jan 05, 1981 | Substantially Equivalent | ASSOCIATED MEDICAL PRODUCTS CO. |
| K802088 | AUXILIARY TRAY | Nov 28, 1980 | Substantially Equivalent | AMERICAN PHARMASEAL DIV. AHSC |
| K802570 | A.M.P.C.O. SKIN SCRUB TRAY | Nov 14, 1980 | Substantially Equivalent | ASSOCIATED MEDICAL PRODUCTS CO. |
| K801965 | CUSTOM UNIVERSAL CUTDOWN PREP TRAY | Oct 10, 1980 | Substantially Equivalent | AMERICAN PHARMASEAL DIV. AHSC |
| K801964 | CUSTOM LYMPHANGIOGRAM ACCES. PACK-STERI | Oct 10, 1980 | Substantially Equivalent | AMERICAN PHARMASEAL DIV. AHSC |
| K801470 | MICRO CLIP STERILIZING CASE #65199 | Jul 14, 1980 | Substantially Equivalent | EDWARD WECK, INC. |
| K800418 | ADT DISPOSABLE THIN NEEDLE ASPIRATION | Apr 28, 1980 | Substantially Equivalent | A.D.T. LAB INDUSTRIES |
| K800367 | MICRESURGICAL TRAY, SM.,MED., & LG. | Mar 10, 1980 | Substantially Equivalent | EDWARD WECK, INC. |
| K791889 | SUTURE REMOVAL TRAY, REORDER 7950&7951 | Oct 17, 1979 | Substantially Equivalent | ASCEP, INC. |
| K791887 | CENTRAL VENOUS CATHETER DRESSING TRAY | Oct 17, 1979 | Substantially Equivalent | ASCEP, INC. |
| K791743 | WECK RACK (STERILIZING ACCESSORY TRAY) | Sep 26, 1979 | Substantially Equivalent | EDWARD WECK, INC. |
| K770428 | VARIOUS SURG. & DIAGNOSTIC INSTRU. ETC. | Sep 12, 1979 | Substantially Equivalent | HOLCO INSTRUMENT CORP. |
| K772266 | INSTRUMENT TRAY | Jan 20, 1978 | Substantially Equivalent | MEDFUSION SYSTEMS, INC. |
| K771680 | ARMOR-KOT SURGICAL INSTRUMENTS | Nov 28, 1977 | Substantially Equivalent | STORZ INSTRUMENT CO. |
| K760579 | INSTRUMENT RACK FOR DAWSON-YUHL INSTR. | Nov 02, 1976 | Substantially Equivalent | V. MUELLER O.V. BAXTER HEALTHCARE CORP. |
| K760428 | SUTURE RACK & NEEDLE COUNTER | Nov 02, 1976 | Substantially Equivalent | KLEEN TEST PRODUCTS |
| K760311 | INSTRUMENTS, GENERAL HAND & SURGERY | Aug 09, 1976 | Substantially Equivalent | DEPUY, INC. |
FEI Numbers
This FDA classification entry is associated with 880 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 880 registration numbers. Click on an entry to view related FDA registrations.