ClearanceBrief
Panels › Gastroenterology, Urology › Product code KOE · Class 2

Dilator, Urethral

Regulation 876.5520

0510(k)s in 12 months (27 all time)
0recalls in 12 months (3 all time)
3recalls that name a 510(k)
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Top companies in KOE

Company510(k)sRecalls
American Medical Systems, Inc.40
Vance Products, Inc.40
Cook Urological, Inc.21
Advanced Surgical Intervention, Inc.20
Atrion Medical Products, Inc.20
Cook Inc.02
G.D. Searle and Co.20
Van-Tec, Inc.20
American Edwards Laboratories10
Boston Scientific Corp10
DateFirm and productCodeLinked 510(k)
Jan 4, 2019Cook Inc.
Urethral Dilator Set, Global Product No. G14185
Terminated		 KOEK811833
Jan 4, 2019Cook Inc.
Urethral Dilation Balloon Catheter with Open Tip , Global Product No. G17844
Terminated		 KOEK892855
Sep 24, 2005Cook Urological, Inc.
Cook brand Fascial Dilator; 10FR/37cm, sterile, Rx Only, Cook Ireland Ltd., Limerick, Ireland; REF G14191; Catalog No. 073710.
Terminated		 KOEK811833

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