Atlas FDA

GES

48 FDA 510(k) clearances · Product code

29 daysmedian time to decision
67 days90th percentile
48clearances measured

FDA profile

Official device name
Blade, Scalpel
Device class
Class I (low risk)
Regulation
21 CFR 878.4800
Medical specialty
General, Plastic Surgery
Adverse events (MAUDE)
2021: 35 · 2022: 21 · 2023: 28 · 2024: 33 · 2025: 40 · 2026: 28
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
PERSONNA PLUS SAFETY SCALPEL SYSTEM (K032242)Omi Manufacturing Pty., Ltd.2003-09-23
EASY-ON (K932998)Devon Industries, Inc.1993-08-18
LOS ALAMOS RETRACTABLE KNIFE (K923170)Innovative Surgical Technology, Inc.1993-02-18
SCALPEL BLADE REMOVER (BLADEGARD) (K915119)Intergrated Visual, Inc.1992-05-05
PRECISION GLIDE - ENHANCED SURGICAL BLADE (K911913)Bd Becton Dickinson Vacutainer Systems Preanalytic1991-05-13
STERILE CARBON STEEL SURGICAL BLADE (K900266)Rahn Laboratories1990-03-01
ANCHOR DOUBLE-EDGE MYRINGOTOMY BLADE (K884862)Anchor Products Co.1988-12-27
SURGICAL BLADE (K881638)Far East Intl. Trading Corp.1988-06-15
SURGICAL BLADES (K880244)Ailee C/O Havel'S, Inc.1988-02-10
NINJA SCALPEL (K873493)Primrose Medical, Inc.1987-09-24
PERSONNA DISPOSABLE SCALPEL (K873142)American Safety Razor Co.1987-09-04
DEXTRA DISPOSABLE BLADES (K863867)Storz Instrument Co.1986-10-24
SABLE BLADES (K863885)Sable Industries1986-10-24
KEISEI SURGICAL BLADES (STERILE & NON-STERILE) (K863211)Keisei Medical Industrial Co., Ltd.1986-09-02
KEISEI MICRO-BLADES (STERILE AND NON-STERILE) (K863214)Keisei Medical Industrial Co., Ltd.1986-09-02
ANGIOMED SKIN FASCIA KNIFE (K855104)Angiomed U.S., Inc.1986-01-24
BLADES, SCALPEL STAINLESS STEEL (K854859)Medelec Intl. Corp.1985-12-24
BLADES, SCALPEL CARBON STEET (K854860)Medelec Intl. Corp.1985-12-24
SURGICAL BLADES (K854620)Niraj Industries1985-12-17
BLADE, SCALPEL (K854561)Medelec Intl. Corp.1985-12-02
STAINLESS STEEL & CARBON STEEL STERILE BLADES (K853528)Abco Dealers, Inc.1985-09-24
APOLLO STERILE BLADES (K852661)Orthofab, Inc.1985-07-11
STERILE SURGICAL BLADES (K852141)Miltex Instrument Co.1985-06-13
SURGIMED - SURGICAL BLADES (K851157)Surgimed Corp.1985-04-25
SURGICAL SCALPEL BLADES & DISPOSABLES (K844759)Cross Country Paper Products Corp.1985-01-18
LANCE BLADES & SCALPELS (K844001)Perry, Div.1984-11-08
SURGEON'S BLADES STERILE BLADE (K841883)An-Med Intl.1984-06-05
PERCUTANEOUS TRIG. FINGER RELEASE KNIFE (K841320)Anapach Effort, Inc.1984-04-24
FASCIA CUTTER (K834514)Stryker Corp.1984-03-12
JAKOBI SURG. INSTRUMENTS #1 19/10/26 (K834194)Imm Enterprises , Ltd.1984-01-27
H.R. JAKOBI SURG. INSTRUMENTS #11 27/37 (K834182)Imm Enterprises , Ltd.1984-01-27
JAKOBI SURG. INSTRUMENTS #11 11/13/14 (K834195)Imm Enterprises , Ltd.1984-01-27
DISP. MICROSURGICAL KNIVES (K821737)Coburn Optical Ind., Inc.1982-07-02
SURGICAL BLADES & SCAPELS (SMPL. W/510K) (K812516)Needle Industries(Usa), Inc.1981-10-02
MICRO BLADE II (K812526)Vxtra Corp.1981-09-16
MICROSURGICAL BLADE (K812160)Vxtra Corp.1981-08-31
RK IV SURGICAL BLADES (K812071)Santa Barbara Medco, Inc.1981-08-31
BLADE, HANDLE, SCALPEL FORCEPS, SURGERY (K810572)Technical Resources, Inc.1981-03-20
BLADE, 20 ANGLE/MICRO BLADE HOLDER (K781716)Edward Weck, Inc.1978-10-24
BLADES, SCALPEL (K771045)American Safety Razor Co.1977-06-22
HANDLES, BLADE, SURGICAL (K770800)Lukens Corp.1977-05-06
BLADES, SURGICAL, STERILE (K770798)Lukens Corp.1977-05-06
LANCE LTD. STERI. STITCH CUTTER BLADE (K770217)Aeroceuticals1977-03-30
SURGICAL BLADES (K761322)Richard-Allan Medical Ind., Inc.1977-01-06
LIGHTCAST II CARBIDE BLADE (K760605)Merck, Sharp & Dohme1976-10-05
BLADE, SURGICAL SCALPEL, STERILE (K760361)Aeroceuticals1976-09-13
SCALPEL, SURGICAL, STERILE STAINLESS (K760363)Aeroceuticals1976-09-13
HANDLE, SCALPEL, STAINLESS STEEL (K760364)Aeroceuticals1976-09-13

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