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Endoscopic Applicator, 41 cm

by Micromedics, Inc.

510(k) K241739

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

Source FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Special NumberK241739 Date15 Jul 2024ClearedStatusActive

Official records

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  • Withdrawn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
GCJ
Device class
Class II
Regulation
21 CFR Part 876.1500
Advisory committee
Gastroenterology, Urology
FDA decision
SESE Substantially Equivalent

Overview

AI-generated summary, 19 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Endoscopic Applicator, 41 cm, is a medical device classified under 21 CFR 876.1500 as an endoscope accessory. It is designed for endoscopic procedures to deliver hemostatic agents to bleeding sites within the body via a 5 mm or larger trocar, aiding in surgical hemostasis during gastrointestinal or urological interventions.

This device is supplied sterile for single-use and is intended for use in controlled clinical settings such as operating rooms or endoscopy suites. It is regulated under FDA 510(k) clearance (K241739) as a Class II medical device, adhering to strict manufacturing and performance standards. The 41 cm length ensures compatibility with standard endoscopic instruments, and its design complies with regulatory requirements for endoscopic accessories in gastroenterology and urology.

Devices cleared under K241739

1 device · FDA GUDID

Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.

Devices cleared under K241739
UDI-DISize and differences
Baxter 0600225
Micromedics, Inc.
060022500815634021488 —On the market

Similar devices

Other devices filed under FDA product code GCJ (Laparoscope, General & Plastic Surgery).

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