Atlas FDA

GZX

13 FDA 510(k) clearances · Product code

83 daysmedian time to decision
118 days90th percentile
13clearances measured

FDA profile

Official device name
Instrument, Microsurgical
Device class
Class I (low risk)
Regulation
21 CFR 882.4525
Medical specialty
Neurology
Adverse events (MAUDE)
1992: 2 · 2004: 4 · 2008: 3 · 2013: 9
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
MICROSURGICAL INSTRUMENTS (K932169)American Russian Medical Services, Inc.1993-07-20
CLARUS ENDOSCOPIC BALL PROBE (K926048)Clarus Medical Systems, Inc.1993-04-07
J105 JAMES SURGICAL SYSTEM I/A PACK (K911932)O.R. Specialties, Inc.1991-08-26
MICROSURGICAL KERATOME (K890216)Kinetic Medical Products1989-02-16
RANGE OF CROCODILE ACTION INSTRUMENTS (K873934)Downs Surgical , Ltd.1987-12-17
RANGE OF NEUROSURGICAL INSTRUMENTS IN TITANIUM (K873933)Downs Surgical , Ltd.1987-12-17
MICRA MICROSURGICAL INSTRUMENTS (K862971)Cordis Corp.1986-08-25
THE VICKERS STANDARD MICROSURGERY SET (K853161)Keeler Instruments, Inc.1985-11-07
VICKERS ERGOMATIC MICROSUR INSTRU-UNIV R O L HAND (K853179)Keeler Instruments, Inc.1985-11-07
VICKERS ERGOMATIC MICROS INSTR-LONG R OR L HANDED (K853180)Keeler Instruments, Inc.1985-10-28
VICKERS ERGOMATIC MICROS INSTR-FINE R OR L HANDED (K853181)Keeler Instruments, Inc.1985-10-28
UNIVERSAL INSTRU. SET FOR NEUROVASCULAR (K831071)Prothia USA, Inc.1983-06-08
DUJOVNY MICROSURGICAL SCISSORS (K810485)American V. Mueller1981-02-27

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