Cotton-Huibregtse Stent, Cotton-Leung Biliary Stent, Cotton-Leung Sof-Flex Biliary Stent, Soehendra Tannenbaum Biliary Stent, Zimmon Biliary Stent, Guiding Catheter, Pushing catheter, Fusion pushing catheter, Stent Introducer Set, Fusion Oasis One Action Sent Introduction System, Zimmon Biliary Stent Set, Oasis One Action Stent Introduction System, Solus Double Pigtail Stent and Introduction System, Cotton-Huibregtse Biliary Stent Set, Cotton-Leung Biliary Stent Set, Oasis One Action S

FDA 510(k) clearance K172044 · decided 2018-02-27

Clearance details

K-number

K172044

Device name

Cotton-Huibregtse Stent, Cotton-Leung Biliary Stent, Cotton-Leung Sof-Flex Biliary Stent, Soehendra Tannenbaum Biliary Stent, Zimmon Biliary Stent, Guiding Catheter, Pushing catheter, Fusion pushing catheter, Stent Introducer Set, Fusion Oasis One Action Sent Introduction System, Zimmon Biliary Stent Set, Oasis One Action Stent Introduction System, Solus Double Pigtail Stent and Introduction System, Cotton-Huibregtse Biliary Stent Set, Cotton-Leung Biliary Stent Set, Oasis One Action S

Applicant

Cook Ireland, Ltd.

Decision

Substantially Equivalent

Date received

2017-07-06

Decision date

2018-02-27

Days to decision

236 days

Clearance type

Traditional

Product code

FGE

Device class

2

Regulation number

876.5010

Medical specialty

Gastroenterology, Urology

Advisory committee

Gastroenterology, Urology

Location

Limerick, IE

Third-party review

No

Expedited review

No

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Similar devices under this product code

Devices cleared under the same product code - the starting set for predicate research.

Recalls involving this device

No recalls on record reference this clearance.

PMA approvals by this applicant