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Knott Ng Tube

by Michael M. Knott, M.D.

510(k) K971354

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK971354 Date19 Nov 1997ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 6 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  • Withdrawn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
FEG
Device Class
Class II
Regulation
21 CFR Part 876.5980
Advisory Committee
Gastroenterology, Urology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 20 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 KNOTT Nasogastric Tube is a Tube, Double Lumen for Intestinal Decompression and/or Intubation, designed for gastric and intestinal drainage or feeding. Its dual-lumen construction allows simultaneous aspiration of gastric contents and administration of nutrients or medications, reducing the need for multiple tubes. This device is intended for use in gastroenterology and urology procedures, where precise placement and reliable function are critical.

The KNOTT Nasogastric Tube is supplied as a single-use, sterile medical device, classified under FDA product code FEG and regulation 876.5980. It is intended for hospital or clinical settings and must be handled with aseptic techniques. The device received FDA 510(k) clearance in 1997 under K-number K971354, with a traditional review process through the Gastroenterology/Urology advisory committee. No additional regulatory markings or special handling (e.g., MRI safety) are specified.

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