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Jarit Take-Apart Endoscopic Instruments

by Integra Lifesciences Corporation

510(k) K103726

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

1 closed

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 11 Oct 2026. What this means

Regulatory status

as of registry sync 11 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK103726 Date8 Feb 2012ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-2028-2012 FDA Class II initiated 23 May 2012

    The Integra(TM) Jarit(R) Take-Apart Laparoscopic Instrument shafts were released with internal component out of specification.

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  • Withdrawn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
KNF
Device Class
Class II
Regulation
21 CFR Part 884.4160
Advisory Committee
Obstetrics/Gynecology
FDA Decision
SESE Substantially Equivalent

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