FSM · Class I · 21 CFR 878.4800

FDA Product Code FSM: Tray, Surgical, Instrument

Leading manufacturers include Medical Device Inspection Co., Inc., Edward Weck, Inc. and American Pharmaseal Div. Ahsc.

76
Total
76
Cleared
66d
Avg days
1976
Since

FDA 510(k) Cleared Tray, Surgical, Instrument Devices (Product Code FSM)

76 devices
1–24 of 76
Cleared Aug 29, 1991
ARTHROSCOPY TRAY
K912106
Medical Device Inspection Co., Inc.
General & Plastic Surgery · 108d
Cleared Aug 26, 1991
OPEN HEART TRAY
K912053
Medical Device Inspection Co., Inc.
General & Plastic Surgery · 109d
Cleared Aug 20, 1991
HEART CATH TRAY
K912052
Medical Device Inspection Co., Inc.
General & Plastic Surgery · 103d
Cleared Aug 09, 1991
MAJOR BASIN TRAY
K912104
Medical Device Inspection Co., Inc.
General & Plastic Surgery · 88d
Cleared Feb 13, 1990
STERILE LACERATION TRAY CAT. #749
K900479
Busse Hospital Disposables, Inc.
General & Plastic Surgery · 12d
Cleared Apr 10, 1987
MEDSURG PERCUTANEOUS ASPIRATION BIOPSY (PAB) TRAY
K870892
Medsurg Industries, Inc.
General & Plastic Surgery · 36d
Cleared Jan 14, 1983
HANDI-TRAY
K823438
Treace Medical, Inc.
General & Plastic Surgery · 59d
Cleared Oct 14, 1981
OPERATING ROOM KIT
K811916
American Hospital Supply Corp.
General & Plastic Surgery · 105d
Cleared Nov 28, 1980
AUXILIARY TRAY
K802088
American Pharmaseal Div. Ahsc
General & Plastic Surgery · 87d
Cleared Oct 10, 1980
CUSTOM LYMPHANGIOGRAM ACCES. PACK-STERI
K801964
American Pharmaseal Div. Ahsc
General & Plastic Surgery · 52d
Cleared Oct 10, 1980
CUSTOM UNIVERSAL CUTDOWN PREP TRAY
K801965
American Pharmaseal Div. Ahsc
General & Plastic Surgery · 52d
Cleared Jul 14, 1980
MICRO CLIP STERILIZING CASE #65199
K801470
Edward Weck, Inc.
General & Plastic Surgery · 20d
Cleared Mar 10, 1980
MICRESURGICAL TRAY, SM.,MED., & LG.
K800367
Edward Weck, Inc.
General & Plastic Surgery · 19d
Cleared Sep 26, 1979
WECK RACK (STERILIZING ACCESSORY TRAY)
K791743
Edward Weck, Inc.
General & Plastic Surgery · 16d
Cleared Nov 28, 1977
ARMOR-KOT SURGICAL INSTRUMENTS
K771680
Storz Instrument Co.
General & Plastic Surgery · 83d
Cleared Nov 02, 1976
INSTRUMENT RACK FOR DAWSON-YUHL INSTR.
K760579
V. Mueller O.V. Baxter Healthcare Corp.
General & Plastic Surgery · 60d
Cleared Aug 09, 1976
INSTRUMENTS, GENERAL HAND & SURGERY
K760311
Depuy, Inc.
General & Plastic Surgery · 14d

About Product Code FSM - Regulatory Context