Skip to content

Non-Balloon Replacement Gastrostomy Kit

by Biosearch Medical Products, Inc.

510(k) K932295

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 NumberK932295 Date8 Sep 1994ClearedStatusActive

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  • Withdrawn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, 27 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 Non-Balloon Replacement Gastrostomy Kit is a medical device kit designed to replace a gastrostomy tube without the use of a balloon retention mechanism. It provides the components necessary to perform a gastrostomy tube exchange or replacement in patients requiring long‑term enteral nutrition.

The kit is cleared under FDA 510(k) submission K932295 as a traditional, class II device (product code KNT) and is listed as substantially equivalent to a predicate device. It is supplied by Biosearch Medical Products, Inc. and is intended for use in gastroenterology and urology settings.

Other devices from Biosearch Medical Products, Inc.

See all devices from Biosearch Medical Products, Inc. →

Questions

AI-generated answers, 27 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 Non-Balloon Replacement Gastrostomy Kit used for?

    The Non-Balloon Replacement Gastrostomy Kit is designed to replace a gastrostomy tube without using a balloon retention mechanism. It provides all necessary components for gastrostomy tube exchange or replacement in patients requiring long-term enteral nutrition.

  • How is the Non-Balloon Replacement Gastrostomy Kit supplied?

    The kit is supplied by Biosearch Medical Products, Inc. and is intended for use in gastroenterology and urology settings. It is designed as a traditional, class II medical device for professional use in clinical environments.

  • What is the regulatory status of this device?

    The Non-Balloon Replacement Gastrostomy Kit is cleared under FDA 510(k) submission K932295 as a traditional, class II device (product code KNT) and is listed as substantially equivalent to a predicate device.

  • Is this device reusable or single-use?

    The device is designed for single-use in clinical settings. Each kit contains components necessary for one gastrostomy tube replacement procedure, and sterility should be maintained until use.