Skip to content

Pathway Balloon Expandable Ureteral Access Sheath, Model Beus

by Onset Medical Corporation

510(k) K061009

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

9 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 · Special NumberK061009 Date2 May 2006ClearedStatusActive

Recalls

9 recalls · FDA

  • 9 recalls, same reason

    • Terminated Z-0906-2008 FDA Unclassified (pre-2012) initiated 30 Nov 2007
    • Terminated Z-0912-2008 FDA Unclassified (pre-2012) initiated 30 Nov 2007
    • Terminated Z-0908-2008 FDA Unclassified (pre-2012) initiated 30 Nov 2007
    • Terminated Z-0905-2008 FDA Unclassified (pre-2012) initiated 30 Nov 2007
    • Terminated Z-0913-2008 FDA Unclassified (pre-2012) initiated 30 Nov 2007
    • Terminated Z-0911-2008 FDA Unclassified (pre-2012) initiated 30 Nov 2007
    • Terminated Z-0909-2008 FDA Unclassified (pre-2012) initiated 30 Nov 2007
    • Terminated Z-0910-2008 FDA Unclassified (pre-2012) initiated 30 Nov 2007
    • Terminated Z-0907-2008 FDA Unclassified (pre-2012) initiated 30 Nov 2007

    Sheath Removal Difficulty: Users experience difficulty in removing the sheath.

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  • Withdrawn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

Other devices from Onset Medical Corporation

See all devices from Onset Medical Corporation →