Atlas FDA

EXPEL NEPHROURETERAL DRAINAGE STENT WITH TWIST-LOC HUB SYSTEM, EXPEL URETERAL DRAINAGE STENT SYSTEM

FDA 510(k) clearance K141344 · decided 2014-10-17

Clearance details

K-number
K141344
Device name
EXPEL NEPHROURETERAL DRAINAGE STENT WITH TWIST-LOC HUB SYSTEM, EXPEL URETERAL DRAINAGE STENT SYSTEM
Applicant
Boston Scientific Corp
Decision
Substantially Equivalent
Date received
2014-05-22
Decision date
2014-10-17
Days to decision
148 days
Clearance type
Traditional
Product code
FAD
Device class
2
Regulation number
876.4620
Medical specialty
Gastroenterology, Urology
Advisory committee
Gastroenterology, Urology
Location
Maple Grove, MN, US
Third-party review
No
Expedited review
No

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Recalls involving this device

No recalls on record reference this clearance.

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