Atlas FDA

RocaJJ Soft Stents

FDA 510(k) clearance K173734 · decided 2018-03-12

Clearance details

K-number
K173734
Device name
RocaJJ Soft Stents
Applicant
Promepla Sam
Decision
Substantially Equivalent
Date received
2017-12-06
Decision date
2018-03-12
Days to decision
96 days
Clearance type
Traditional
Product code
FAD
Device class
2
Regulation number
876.4620
Medical specialty
Gastroenterology, Urology
Advisory committee
Gastroenterology, Urology
Location
Monaco, MC
Third-party review
No
Expedited review
No

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Recalls involving this device

No recalls on record reference this clearance.