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Mediflex Modular III Basic Laparoscopic Instruments 92142-45-3

by Flexbar Machine Corp.

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

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

510(k) K974382

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 Number00842102104060 UDI-DI Date17 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK974382 Date21 Apr 1998DecidedStatusActive

Official records

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Mediflex Modular III Basic Laparoscopic Instruments
Generic name
Rigid endoscopic tissue manipulation forceps, reusable
Model / Ref / Catalog
92142-45-3
Primary DI / UDI-DI
00842102104060
510(k) Number
FDA product code
GCJ
GMDN term
Rigid endoscopic tissue manipulation forceps, reusable
Device class
Class II
Regulation number
876.1500
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Other devices from Flexbar Machine Corp.

See all devices from Flexbar Machine Corp. →

Properties

  • Sterilise before use
  • Manufacturing date

Other properties (13)

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