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Panels › Gastroenterology, Urology › Product code OCY · Class 2

Endoscopic Guidewire, Gastroenterology-Urology

Regulation 876.1500

0510(k)s in 12 months (43 all time)
0recalls in 12 months (10 all time)
8recalls that name a 510(k)
Get daily alerts for OCYSample briefCSV

Top companies in OCY

Company510(k)sRecalls
Cook Inc.09
Boston Scientific Corp50
Wilson-Cook Medical, Inc.50
Lake Region Medical40
Neometrics, Inc.30
C.R. Bard, Inc.20
Coloplast A/S20
Flexmedics20
Terumo Corp.20
Terumo Medical Corp.20
DateFirm and productCodeLinked 510(k)
Sep 28, 2022Cook Incorporated
Roadrunner PC Hydrophilic Wire Guide, Hydrophilic Guidewire Reference Part Number/GPN: RPC-035145-0-5 G34131 RPC-035145 G18154 RPC-035145-5 G34132 RPC-038145-0-5 G34129 RFSPC-038145-0 G17539 RFSPC-035
Open, Classified		 OCYK082536
Jan 4, 2019Cook Inc.
Angled Tip Ureteral Catheter Set with Bentson PTFE Wire Guide, Ureteral Catheter, Global Product No. G19108 G14587 G15302 G14326
Terminated		 OCYNone listed
Jan 4, 2019Cook Inc.
Angled Tip Ureteral Catheter Set, Ureteral Catheter, Global Product No. G14598
Terminated		 OCYNone listed
Jan 4, 2019Cook Inc.
Wire Guide, Guidewire, Global Product Number G14326
Terminated		 OCYK082536
Jan 4, 2019Cook Inc.
Roadrunner Hydrophilic PC Wire Guide, Guidewire, Global Product Number G18629, G17866
Terminated		 OCYK082536
Jan 4, 2019Cook Inc.
PTFE Wire Guide, Guidewire, Global Product Number 638813 635413-10
Terminated		 OCYK082536
Jan 4, 2019Cook Inc.
Heavy Duty PTFE Wire Guide, Guidewire, Global Product Number G14323 G14260 G14260
Terminated		 OCYK082536
Jan 4, 2019Cook Inc.
Fixed Core Straight Safety Wire Guide, Guidewire, Global Product Number G14285
Terminated		 OCYK082536
Jan 4, 2019Cook Inc.
Bentson PTFE Wire Guide, Guidewire, Global Product Number G14589, G14590
Terminated		 OCYK082536
Jun 10, 2014NEO METRICS, INC.
Boston Scientific, NovaGold High Performance Guidewire, Rx only, Sterilized using ethylene oxide, UPN M00552010 and M00552000, Manufactured by NeoMetrics Inc, 2605 Fernbrook Lane Suite J, Plymouth, MN
Terminated		 OCYK133076

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