Atlas FDA

GEY

41 FDA 510(k) clearances · Product code

78 daysmedian time to decision
160 days90th percentile
41clearances measured

FDA profile

Official device name
Motor, Surgical Instrument, Ac-Powered
Device class
Class I (low risk)
Regulation
21 CFR 878.4820
Medical specialty
General, Plastic Surgery
Adverse events (MAUDE)
2021: 1,145 · 2022: 1,360 · 2023: 1,444 · 2024: 1,447 · 2025: 980 · 2026: 615
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
ADVANCED TURBO DRIVE SYSTEM (K050519)Linvatec Corp.2005-05-17
ARTHROCARE CONTROLLER; ARTHROCARE CABLE; FOOT CONTROL; POWER CORD; WANDS (K020621)Arthrocare Corp.2002-03-28
SYMPHONY GRAFT DELIVERY SYSTEM (GDS) (K012738)Depuyacromed2001-11-14
MEDNEXT 1000 DRILL (K972308)Mednext, Inc.1997-08-20
AQUA SPRAY (K971941)Boyd Industries, Inc.1997-08-14
BONE AND MARROW COLLECTION SYSTEM KIT (K971782)Biomedical Ent., Inc.1997-07-29
BONE & MARROW CLLECTION SYSTEM (K971268)Biomedical International Corp.1997-07-03
ORTHOCHUCK (K964252)Buckman Co., Inc.1997-05-27
ANSPACH LUBRICATING SYSTEM II (K970530)The Anspach Effort, Inc.1997-05-05
BME BONE DRILL BITS (K964073)Biomedical Ent., Inc.1996-11-14
SURGICAL KIT-ACUFEX MOSAICPLASTY SYSTEM (K962789)Smith & Nephew Endoscopy, Inc.1996-08-14
BONE & MARROW COLLECTION SYSTEM (K961901)Biomedical Ent., Inc.1996-08-06
SURGIMOTOR (K954470)W.O.M. World of Medicine GmbH1995-12-08
PODOSPRAY DRILL SYSTEM (K951773)Darco Intl., Inc.1995-10-26
KARL STORZ DRILL (K952008)KARL STORZ Endoscopy-America, Inc.1995-07-26
3M MAXI-DRIVER II ELECTRIC SYSTEM (K951118)3M Company1995-07-06
AUTO LUBE SYSTEM (K940535)The Anspach Effort, Inc.1994-03-21
ACRO-POLY, INC. HANDPIECE/ANGLEHEAD ACCESSORIES FOR SURGICAL INSTUMENTS (K934172)Acro-Poly, Inc.1993-10-27
CUTO(TM) TISSUE MORCELLATION SYSTEM (K932700)Linvatec Corp.1993-10-15
ES-100 POWER SYSTEM, ES-100 SERIES (K925360)Elekta Instruments, Inc.1993-09-07
AESCULAP SURGICAL ACCESSORIES (K913262)Aesculap, Inc.1991-12-30
MICRO-AIRE MODEL 2060 (K913369)Micro Surgical Instruments Corp.1991-11-01
MICRO-AIRE MODEL 2050E/ELEC HANDPIECE/TROTTLELESS (K913266)Micro Surgical Instruments Corp.1991-10-21
2710-000 OSCILLATING SAW, GENERAL ASSEMBLY (K905383)Micro Surgical Instruments Corp.1991-06-18
VISTEK ELECTRONIC CONTROLLER (K904682)Vistek Corp.1990-12-18
MICRO-AIRE POWERED MICRO-SURGERY INSTRUMENTS (K900033)Micro-Aire Surgical Instruments, Inc.1990-02-13
PHYSIOTRON(TM) MICROSURGICAL MOTOR & COOLING SYS. (K882654)Surgical Innovators of America, Inc.1988-09-20
MICRO-TORQUE HAND ENGINE & ACCESS. DERMABRA. BURS (K873475)Mcghan Medical Corp.1987-09-11
MINI-MOTOR HAND ENGINE & ACCESS. DERMABRASION BURS (K873476)Mcghan Medical Corp.1987-09-11
THE DEXTRA PRECISION POWER UNIT (K853778)Storz Instrument Co.1985-11-13
DRILLING TEMPLATE (K853761)Orthopedic Systems, Inc.1985-10-07
ISOMETRIC ACL DRILL GUIDE (K853762)Orthopedic Systems, Inc.1985-10-07
MULTIPLE OUTLET MANIFOLD (K850389)The Anspach Effort, Inc.1985-03-18
MINUTEMAN CO2 MICROSURG LASER GEN SURG (K843519)American Surgical Laser, Inc.1984-12-07
MINUTEMAN C02 MICROSURG LASER PODIATRY (K843518)American Surgical Laser, Inc.1984-12-07
MINUTEMAN CO2 MICROSURG LASER DERMATOL- (K843517)American Surgical Laser, Inc.1984-12-07
RICHARDS INTRA-ARTICULAR SHAVER MOTOR (K842475)Richards Medical Co., Inc.1984-09-17
ELECTRO SURGERY SYSTEM (K841165)Micro-Aire Surgical Instruments, Inc.1984-06-05
RICHARDS INTRA-ARTICULAR SHAVER BLADES (K830153)Richard'S Medical Equip., Inc.1983-02-28
SAGITTAL SAW (K812438)Black & Decker(Tm)1981-11-02
150 DRIVER REAMER (K812437)Black & Decker(Tm)1981-11-02

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Every clearance here is in the API, with alerts when new ones post.