Atlas FDA

FZS

14 FDA 510(k) clearances · Product code

29 daysmedian time to decision
111 days90th percentile
14clearances measured

FDA profile

Official device name
Curette, Surgical, General Use
Device class
Class I (low risk)
Regulation
21 CFR 878.4800
Medical specialty
General, Plastic Surgery
Adverse events (MAUDE)
2005: 3 · 2006: 5 · 2007: 3 · 2008: 3 · 2010: 4 · 2011: 6
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
SURGICAL CURETTE (K932493)Whitney Products, Inc.1994-01-07
KEVTEK(TM) LASER DRAPE/ORGAN PROTECTOR/EYE SHIELD (K902000)Kevtek Medical Products, Inc.1990-08-21
CYMED MICROSKIN(R) DISPOSABLE IRRIGATION SLEEVE (K892521)Cymed, Inc.1989-05-01
CURRETTES - PIFFARD, WOLF, VIDAL-SCRAPER (K891888)Zinnanti Surgical Instruments, Inc.1989-04-12
ACU-CURETTE (K891334)Acuderm, Inc.1989-04-11
ADENOID CURETTE (K890366)Kinetic Medical Products1989-02-03
MICRODISCECTOMY CURETTE SET (K875292)T. Korossurgical Instruments Corp.1988-01-29
STRAIGHT CUP CURRETTE, 1.7MM (K871925)Arthropedics, Inc.1987-06-01
RANDALL CURETTE (K854888)Euro-Med Intl.1985-12-24
NOVAK CURETTE (K854899)Euro-Med Intl.1985-12-24
HOPPENSTEIN MICROSURGICAL SPINAL INSTRU (K842701)Downs Surgical , Ltd.1984-08-02
PMN VOLZ CURETTES (K831367)3M Company1983-05-25
LUO CURRETTES #3211 (K831119)Pmt, Inc.1983-05-09
ANSPACH MENISECTOMY KNIFE (K803178)The Anspach Effort, Inc.1981-02-13

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