GES · Class I · 21 CFR 878.4800

FDA Product Code GES: Blade, Scalpel

Leading manufacturers include Aeroceuticals, Medelec Intl. Corp. and Imm Enterprises , Ltd..

48
Total
48
Cleared
39d
Avg days
1976
Since

FDA 510(k) Cleared Blade, Scalpel Devices (Product Code GES)

48 devices
1–24 of 48
Cleared Sep 23, 2003
PERSONNA PLUS SAFETY SCALPEL SYSTEM
K032242
Omi Manufacturing Pty., Ltd.
General & Plastic Surgery · 64d
Cleared Aug 18, 1993
EASY-ON
K932998
Devon Industries, Inc.
General & Plastic Surgery · 61d
Cleared Feb 18, 1993
LOS ALAMOS RETRACTABLE KNIFE
K923170
Innovative Surgical Technology, Inc.
General & Plastic Surgery · 234d
Cleared May 05, 1992
SCALPEL BLADE REMOVER (BLADEGARD)
K915119
Intergrated Visual, Inc.
General & Plastic Surgery · 174d
Cleared May 13, 1991
PRECISION GLIDE - ENHANCED SURGICAL BLADE
K911913
Bd Becton Dickinson Vacutainer Systems Preanalytic
General & Plastic Surgery · 13d
Cleared Mar 01, 1990
STERILE CARBON STEEL SURGICAL BLADE
K900266
Rahn Laboratories
General & Plastic Surgery · 42d
Cleared Dec 27, 1988
ANCHOR DOUBLE-EDGE MYRINGOTOMY BLADE
K884862
Anchor Products Co.
General & Plastic Surgery · 36d
Cleared Jun 15, 1988
SURGICAL BLADE
K881638
Far East Intl. Trading Corp.
General & Plastic Surgery · 62d
Cleared Feb 10, 1988
SURGICAL BLADES
K880244
Ailee C/O Havel'S, Inc.
General & Plastic Surgery · 21d
Cleared Sep 24, 1987
NINJA SCALPEL
K873493
Primrose Medical, Inc.
General & Plastic Surgery · 24d
Cleared Sep 04, 1987
PERSONNA DISPOSABLE SCALPEL
K873142
American Safety Razor Co.
General & Plastic Surgery · 25d
Cleared Oct 24, 1986
DEXTRA DISPOSABLE BLADES
K863867
Storz Instrument Co.
General & Plastic Surgery · 21d
Cleared Oct 24, 1986
SABLE BLADES
K863885
Sable Industries
General & Plastic Surgery · 18d
Cleared Sep 02, 1986
KEISEI SURGICAL BLADES (STERILE & NON-STERILE)
K863211
Keisei Medical Industrial Co., Ltd.
General & Plastic Surgery · 13d
Cleared Sep 02, 1986
KEISEI MICRO-BLADES (STERILE AND NON-STERILE)
K863214
Keisei Medical Industrial Co., Ltd.
General & Plastic Surgery · 13d
Cleared Jan 24, 1986
ANGIOMED SKIN FASCIA KNIFE
K855104
Angiomed U.S., Inc.
General & Plastic Surgery · 32d
Cleared Dec 24, 1985
BLADES, SCALPEL STAINLESS STEEL
K854859
Medelec Intl. Corp.
General & Plastic Surgery · 19d
Cleared Dec 24, 1985
BLADES, SCALPEL CARBON STEET
K854860
Medelec Intl. Corp.
General & Plastic Surgery · 19d
Cleared Dec 17, 1985
SURGICAL BLADES
K854620
Niraj Industries
General & Plastic Surgery · 29d
Cleared Dec 02, 1985
BLADE, SCALPEL
K854561
Medelec Intl. Corp.
General & Plastic Surgery · 18d
Cleared Sep 24, 1985
STAINLESS STEEL & CARBON STEEL STERILE BLADES
K853528
Abco Dealers, Inc.
General & Plastic Surgery · 32d
Cleared Jul 11, 1985
APOLLO STERILE BLADES
K852661
Orthofab, Inc.
General & Plastic Surgery · 17d
Cleared Jun 13, 1985
STERILE SURGICAL BLADES
K852141
Miltex Instrument Co.
General & Plastic Surgery · 28d
Cleared Apr 25, 1985
SURGIMED - SURGICAL BLADES
K851157
Surgimed Corp.
General & Plastic Surgery · 34d

About Product Code GES - Regulatory Context