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23 FDA 510(k) clearances · Product code

50 daysmedian time to decision
178 days90th percentile
23clearances measured

FDA profile

Official device name
Motor, Surgical Instrument, Pneumatic Powered
Device class
Class I (low risk)
Regulation
21 CFR 878.4820
Medical specialty
General, Plastic Surgery
Adverse events (MAUDE)
2018: 46 · 2019: 15 · 2020: 15 · 2022: 13 · 2024: 19 · 2026: 20
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
AESCULAP POWER SYSTEM HANDPIECE (K960473)Aesculap, Inc.1996-03-07
SODEM HIGH SPEED SYSTEM FOR NEUROSURGERY & MEDIAN STYERNOTOMY (K955174)Sodem Diffusion SA1996-01-22
NUCLEOTOME L KIT (K942987)Surgical Dynamics, Inc.1995-10-30
MIDAS REX DRILL ATTACHMENTS & TWIST DRILLS (K954076)Midas Rex Pneumatic Tools, Inc.1995-10-18
MIDAS REX TELESCOPING SYSTEM (K953433)Midas Rex Pneumatic Tools, Inc.1995-09-15
ROTATING, FIXED FOOTED, FIXED SHIELD ATTACHMENTS, DISSECTING TOOLS (K953432)Midas Rex Pneumatic Tools, Inc.1995-09-14
GS & GS20 SURGICAL TOOL SYSTEM (K952463)Midas Rex Pneumatic Tools, Inc.1995-07-17
MIDAS REX MOTORS (MIDAS I, II & CONVERTIBLE MODELS) (K952300)Midas Rex Pneumatic Tools, Inc.1995-05-26
AUTO SUTURE(R) ARTICULATING ENDOSCOPIC CLAMP (K914753)United States Surgical, A Division of Tyco Healthc1992-06-11
PORTA GAS COMPRESSED GAS CYLINDER CART (K910071)Sen Tech Medical Corp.1991-03-22
MODIFICATION AUTO SUTURE(R) ENDOSCOPIC CLAMP (K904578)United States Surgical, A Division of Tyco Healthc1990-10-30
HEMATOME SYSTEM (K885066)Surgical Dynamics, Inc.1989-05-01
AMERICAN BRAIN RETRACTOR COVER (K872951)American Silk Sutures, Inc.1987-09-16
STRYKER ORTHOPOWER 90 & ORTHOPOWER 90 SYSTEM II (K863447)Stryker Corp.1986-09-29
BIPOLAR SUCTION ELECTRODE (K843498)Eder Instrument Co, Inc.1984-12-14
SURG-A-STAT VASECTOMY TIP (K840370)Suncoast Medical Manufacturers, Inc.1984-07-23
HALL OSTEON (K833187)Amsco Co.1983-10-31
HALL DRILL/REAMER (K832186)Amsco Co.1983-08-12
HALL RECIPROCATOR (K832188)Amsco Co.1983-08-12
HALL OSCILLATOR (K832187)Amsco Co.1983-08-12
TWIST LOCK DRILL 1120 (K831675)Micro-Aire Surgical Instruments, Inc.1983-06-30
CLEAR-VIEW MIRROR WARMER (K800382)Surgical Mechanical Research, Inc.1980-05-14
FOOT VALVE (K790195)American Safety1979-02-26

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