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Scipro(Tm) Flexible Stone Dislodger and Retrieval Set

by Scion Cardiovascular, Inc.

510(k) K001563

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

2 closed

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK001563 Date22 Nov 2000ClearedStatusActive

Recalls

2 recalls · FDA

    • Terminated Z-0557-04 FDA Unclassified (pre-2012) initiated 30 Jun 2003

    The firm received field complaints that it was difficult to open the stone retrieval basket during use.

    • Terminated Z-0554-04 FDA Unclassified (pre-2012) initiated 23 May 2003

    Possible difficulty for the user in opening the stone retrieval basket.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
FGO
Device Class
Class II
Regulation
21 CFR Part 876.4680
Advisory Committee
Gastroenterology, Urology
FDA Decision
SESE Substantially Equivalent

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