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Mediflex Modular III Basic Laparoscopic Instruments 92147-45-I

by Flexbar Machine Corp.

Mediflex Modular III Basic Laparoscopic Instruments 92147-45-I is a Class II device made by Flexbar Machine Corp., cleared under FDA 510(k) K974382 on 21 Apr 1998 and listed in FDA GUDID since 17 Sep 2016 (UDI-DI 00842102104282), active as of 22 Oct 2026.

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

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00842102104282 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

Across registries

2 registries list this device

  • FDA 510(k) K974382 decided 21 Apr 1998 Active
  • FDA GUDID UDI-DI 00842102104282 listed 17 Sep 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K974382
  2. Listed FDA GUDID 00842102104282

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  • Withdrawn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
92147-45-I
Primary DI / UDI-DI
00842102104282
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, all answered No)