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Porges Ureteral Stent

by Bivona Medical Technologies 510(k)

Active United States

510(k) K881744

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK881744 Date3 May 1988ClearedStatusActive

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
FAD
Device Class
Class II
Regulation
21 CFR Part 876.4620
Advisory Committee
Gastroenterology, Urology
FDA Decision
SESE Substantially Equivalent

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