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Purewrist Scissors, Model PW1101-01;PUREWRIST Dissector, Model PW1201-01;PUREWRIST Hook, Model PW1301-01

by Cambridge Endoscopic Devices

510(k) K061425

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 NumberK061425 Date10 Aug 2006ClearedStatusActive

Recalls

2 recalls · FDA

  • 2 recalls, same reason

    • Terminated Z-2743-2011 FDA Unclassified (pre-2012) initiated 20 May 2011
    • Terminated Z-2744-2011 FDA Unclassified (pre-2012) initiated 20 May 2011

    PET shrink sleeve insulation material dislodging from the distal tips of Autonomy Laparo-Angle (ALA) Metzenbaum Scissors

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  • Withdrawn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
GEI
Models / Variants
Device Class
Class II
Regulation
21 CFR Part 878.4400
Advisory Committee
General, Plastic Surgery
FDA Decision
SESE Substantially Equivalent