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Endoplus E322S

by Endoplus

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None ongoing

2 closed

Documents

None

No authorization documents

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 Number00817401029130 UDI-DI Date6 Feb 2026ListedStatusListed GUDID: in commercial distribution

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  • Withdrawn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 — GUDID listing Listed

Specification

GUDID

Trade Name
Endoplus
Generic Name
Rigid endoscopic tissue manipulation forceps, reusable
Model / Reference
E322S
Description
5mm Biopsy Forcep with Two Teeth Insert, Standard Handle 5mm Fenestrated Bowel Grasper, Standard Handle, With Rotation, Short Length
Primary DI / UDI-DI
00817401029130
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
Sterilization Method
Moist Heat or Steam Sterilization

Related devices

Cleared under the same submission (K925079)

Show all (12)

Other devices from Endoplus

See all devices from Endoplus →

Properties

  • Prescription Use
  • Lot / Batch Number

Other properties (12)

  • 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