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Compat Gastrostomy/Jejunostomy Feeding Tube Kit(088000)

by Sandoz Nutrition

510(k) K965087

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)SESK Substantially Equivalent — Kit · Traditional NumberK965087 Date18 Mar 1997ClearedStatusActive

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  • Withdrawn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
SESK Substantially Equivalent — Kit

Overview

AI-generated summary, 24 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 device is a gastrostomy/jejunostomy feeding tube kit, classified as a gastrointestinal tube and accessory under regulation 876.5980. It is designed for the delivery of formula and medications to the small intestine via the FEED port while allowing simultaneous gastric drainage through the DRAIN port.

The kit is supplied as a single unit and was cleared through the FDA 510(k) process under K965087 with product code KNT. It is intended for use in gastroenterology and urology settings, with no information provided on sterility, single-use or reusable status, MRI safety, sizes, storage conditions, or additional authorisations beyond the FDA 510(k) clearance.

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Questions

AI-generated answers, 24 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 COMPAT gastrostomy/jejunostomy feeding tube kit used for?

    The device is designed for the delivery of formula and medications to the small intestine via the FEED port while allowing simultaneous gastric drainage through the DRAIN port, making it suitable for patients requiring enteral feeding and gastric decompression.

  • How is the COMPAT feeding tube kit supplied and is it sterile or reusable?

    The kit is supplied as a single unit, but the provided data does not specify whether it is sterile, single-use, or reusable; no information on sterility or reuse status is included in the device description.

  • What regulatory pathway was used for the COMPAT feeding tube kit and what is its K number?

    The device was cleared through the FDA 510(k) process under K965087 with product code KNT, as stated in the authorizations and specifications section of the device data.