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Balloon Ureteral Dilators, Accent Dg Balloon Ureteral Dilator Set, Ascend Balloon Dilation Catheters, Balloon Dilation C

by Cook Urological, Inc.

510(k) K990072

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 NumberK990072 Date25 Mar 1999ClearedStatusActive

Recalls

2 recalls · FDA

  • 2 recalls, same reason

    • Terminated Z-0555-03 FDA Unclassified (pre-2012) initiated 22 Jan 2003
    • Terminated Z-0554-03 FDA Unclassified (pre-2012) initiated 22 Jan 2003

    Product is labeled sterile, but was not sterilized.

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  • Withdrawn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
EZN
Device Class
Class II
Regulation
21 CFR Part 876.5470
Advisory Committee
Gastroenterology, Urology
FDA Decision
SESE Substantially Equivalent

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