Atlas FDA

OCY

43 FDA 510(k) clearances · Product code

57 daysmedian time to decision
143 days90th percentile
43clearances measured

FDA profile

Official device name
Endoscopic Guidewire, Gastroenterology-Urology
Device class
Class II (moderate risk)
Regulation
21 CFR 876.1500
Medical specialty
Gastroenterology, Urology
FDA definition
To provide access to gi or gu tract for the purpose of passing or exchanging other accessories.
Adverse events (MAUDE)
2021: 94 · 2022: 134 · 2023: 115 · 2024: 131 · 2025: 135 · 2026: 55
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
EasyPass Guidewire (K153264)Medi-Globe Corporation2016-05-19
Radifocus Glidewire Endoscopic Wire (K151471)Terumo Medical Corporation2015-09-17
Orchestra Hydrophilic Guidewire standard angled, Orchestra Hydrophilic Guidewire straight stiff, Orchestra Hydrophilic Guidewire angled stiff,Orchestra Hydrophilic Guidewire standard straight, Orchestra Hydrophilic Guidewire straight stiff (K150927)Coloplast A/S2015-05-27
NovaGold High Performance Guidewire (K150225)Neometrics, Inc.2015-03-16
Acrobat Calibrated Tip Wire Guide (K142950)Wilson-Cook Medical, Inc.2014-11-05
JAGWIRE HIGH PERFORMANCE GUIDWIRE (K141820)Boston Scientific Corp2014-10-21
Predicate III Guidewire (K142397)Lake Region Medical2014-09-19
MANDREL GUIDEWIRE (K140482)Lake Region Medical2014-04-08
NOVAGOLD HIGH PERFORMANCE GUIDEWIRE (K133076)Neometrics, Inc.2014-02-20
ORCHESTRA HYDROPHILIC GUIDEWIRE STANDARD ANGLED, ORCHESTRA HYDROPHILIC GUIDEWIRE STRAIGHT STIFF, ORCHESTRA HYDROPHILIC (K131072)Coloplast A/S2013-07-09
OSTAVI HYDROPHILIC GUIDEWIRE (K124052)Lake Region Medical2013-02-26
XENX STONE MANAGEMENT DEVICE (K123438)Xenolith Medical2013-01-10
NEO ERCP GUIDEWIRE (K123439)Neometrics, Inc.2013-01-03
AXCESS SOFT TIP WIRE GUIDE (K122816)Wilson-Cook Medical, Inc.2012-10-09
XENX (K113692)Xenolith Medical2012-08-09
SINGLE USE GUIDEWIRE, MODELS G-240-2527S, G-240-2545S, G-240-2527A, G-240-2545A, G-240-3527S, G-240-3545S & G-240-3527A (K091417)Terumo Corp.2009-05-22
COOK WIRE GUIDES (K082536)Cook Urological, Inc.2008-10-27
TAXI ENDOSCOPIC GUIDEWIRE (K081708)Lake Region Mfg., Inc.2008-08-26
MANDREL GUIDEWIRES OR M-WIRE (K080508)Lake Region Medical2008-03-21
GUIDEWIRE, MODEL G-V220-3527S AND OTHERS (K072354)Accellent, Inc.2007-12-07
NIPRO HYDROPHILIC GUIDEWIRE FOR UROLOGICAL & LAPAROSCOPIC USE (K060034)Nipro Medical Corporation2006-02-28
TECHDEVICE GUIDEWIRE (K053028)Techdevice Corporation2006-01-31
FX WIRE ADVANCED MEASUREMENT GUIDEWIRE (K050304)Conmedcorp2005-03-08
WILSON-COOK USW CAP AND WIRE LOCK (K040137)Wilson-Cook Medical, Inc.2004-02-20
TRACER METRO SMART WIRE GUIDE (K033754)Wilson-Cook Medical, Inc.2003-12-30
ENDO-GLIDE GUIDEWIRE (K023603)Endo-Therapeutics, Inc.2003-02-19
DISPOSABLE GUIDEWIRE, MODELS G-205-3545S & G-205-3545A (K021179)Olympus Optical Co., Ltd.2002-07-05
RADIUS NEXT GENERATION GUIDEWIRE (K011759)Radius Medical Technologies, Inc.2001-08-23
FLEXFINDER GUIDE WIRE(REGULAR SHAFT/STIFF SHAFT) MARKED INK BANDS, FLEXFINDER GUIDE WIRE (REGULAR SHAFT/STIFF SHAFT) NO (K990765)Flexmedics1999-03-15
CLIMBER - PARTIALLY COATED GUIDE WIRE FOR ENDOSCOPIC USE (K971937)Terumo Medical Corp.1997-08-15
BARD DIRECTOR GUIDEWIRE (000560) (K964780)C.R. Bard, Inc.1997-02-26
FLEXFINDER GUIDEWIRE (REGULAR SHAFT/STIFF SHAFT) MARKED INK BANDS ENCAP+/GUIDEWIRE(REGULAR SHAFT/STIFF SHAFT) NO MARKING (K964955)Flexmedics1997-02-14
BARD TIGER GUIDEWIRE MODEL 000540 (K962178)C.R. Bard, Inc.1996-10-29
AMPLATZ SUPER STIFF GUIDEWIRE (K944959)Boston Scientific Corp1994-11-04
MICROVASIVE PATHFINDER EXCHANGE GUIDEWIRE INSURG PATHFINDER GUIDEWIRE (K943737)Boston Scientific Corp1994-08-17
OLYMPUS GUIDE WIRE (K933110)Olympus Corp.1993-11-04
FLEX FINDER GUIDEWIRE (K923755)Flex Medics Corporation1993-09-03
MICROVASIVE INSURG GEENEN CBD GUIDE WIRE (K931650)Boston Scientific Corp1993-06-25
WILSON COOK WIRE GUIDE AND PROTECTIVE GUIDE (K910497)Wilson-Cook Medical, Inc.1991-04-02
450CM GUIDE WIRE FOR G.I. USE (K910722)Terumo Corp.1991-03-21
SOFT, SPRING TIPPED NYLON COATED GUIDE WIRE (K901429)Telemed Systems, Inc.1990-06-05
MICROVASIVE ENDOTORQUE GUIDEWIRE, CAT #5177 (K892648)Boston Scientific Corp1989-05-24
GUIDE WIRE (K813026)Inmed Corp.1981-11-17

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