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Endoplus E337RR-45

by Endoplus

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

2 closed

Documents

510(k) K925079

FDA submission, from GUDID

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00817401024005 UDI-DI Date31 Oct 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK925079 Date24 Aug 1994DecidedStatusActive

Recalls

2 recalls · FDA

  • 2 recalls, same reason

    • Terminated Z-2265-2013 FDA Class II initiated 15 Jul 2013 on shared 510(k) K925079
    • Terminated Z-2264-2013 FDA Class II initiated 15 Jul 2013 on shared 510(k) K925079

    Multiple complaints reporting that the moveable jaw has broken during laparoscopic procedures.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Endoplus
Generic name
Rigid endoscopic tissue manipulation forceps, reusable
Model / reference
E337RR-45
Primary DI / UDI-DI
00817401024005
510(k) Number
FDA product code
HET
GMDN term
Rigid endoscopic tissue manipulation forceps, reusable
Device class
Class II
Regulation number
884.1720
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Related devices

Category: Rigid endoscopic tissue manipulation forceps, reusable

Cleared under the same submission (K925079)

Show all (12)

Other devices from Endoplus

  • Endoplus E366RR-45

    Class II

  • Endoplus E367RR-45

    Class II

  • Endoplus E416SR-45

    Class II

  • Endoplus E365RR-45

    Class II

  • Endoplus E404RR-45

    Class II

  • Endoplus E404RR

    Class II

See all devices from Endoplus →

Properties

  • Sterilise before use
  • Prescription use
  • Lot / batch number

Other properties (12)

  • Supplied sterile: No
  • Single use: No
  • Implantable: No
  • Contains latex: No
  • Over-the-counter: No
  • Convenience kit: No
  • Combination product: No
  • HCT/P: No
  • Premarket exempt: No
  • Serial number: No
  • Expiration date: No
  • Manufacturing date: No