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U.S. Endoscopy Group, Inc. Balloon Replacement Gastrostomy Tube

by United States Endoscopy Group, Inc.

510(k) K955181

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

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK955181 Date5 Jun 1996ClearedStatusActive

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  • Withdrawn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
KNT
Device Class
Class II
Regulation
21 CFR Part 876.5980
Advisory Committee
Gastroenterology, Urology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 22 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 U.S. Endoscopy Group, Inc. Balloon Replacement Gastrostomy Tube is a medical device used for gastrostomy, which involves the insertion of a tube into the stomach. It is a balloon replacement type, indicating that it uses a balloon for placement or securement. The device is classified under product code KNT.

The device is supplied by United States Endoscopy Group, Inc. and has received FDA 510K authorization. It is described as substantially equivalent, with a clearance type of traditional. The device is associated with the advisory committee for Gastroenterology and Urology, and its specifications include a summary statement and decision description.

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Questions

AI-generated answers, 22 Sep 2026

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

  • What is the purpose of the Balloon Replacement Gastrostomy Tube?

    The Balloon Replacement Gastrostomy Tube is used for gastrostomy, which involves the insertion of a tube into the stomach, with a balloon for placement or securement, to provide a means of feeding or decompression.

  • How is the device supplied?

    The device is supplied by United States Endoscopy Group, Inc.

  • What is the regulatory status of the device?

    The device has received FDA 510K authorization, with a clearance type of traditional, and is described as substantially equivalent.

  • What product code is the device classified under?

    The device is classified under product code KNT.