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Tri-Med Endoscopic Fluid Introduction Catheter

by Tri-Med Specialties, Inc. 2 variants

510(k) K942918

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Overview

The TRI-MED ENDOSCOPIC FLUID INTRODUCTION CATHETER is a FDA-approved endoscopic irrigation/suction system designed for the treatment of gastroenterological and urological conditions. Its unique features, including a comfortable handling design and a high-viscosity fluid introduction mechanism, make it an effective solution for various medical needs.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK942918 Date28 Feb 1995ClearedStatusActive

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  • Withdrawn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

510(k)

510(k) Number
FDA Product Code
OCX
Device Class
Class II
Regulation
21 CFR Part 876.1500
Advisory Committee
Gastroenterology, Urology
FDA Decision
SESE Substantially Equivalent

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