Cleared Traditional

K971354 - KNOTT NG TUBE

K971354 is an FDA 510(k) clearance for KNOTT NG TUBE, manufactured by Michael M. Knott, M.D.. The device is a Class 2 Gastroenterology & Urology device with product code FEG cleared through the Traditional 510(k) pathway after a 222-day FDA review.

K971354 · Michael M. Knott, M.D. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1997
Decision
222d
Days
Class 2
Risk

K971354 is an FDA 510(k) clearance for the KNOTT NG TUBE. Classified as Tube, Double Lumen For Intestinal Decompression And/or Intubation (product code FEG), Class II - Special Controls.

Submitted by Michael M. Knott, M.D. (Tahoe City, US). The FDA issued a Cleared decision on November 19, 1997 after a review of 222 days - an extended review cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5980 - the FDA gastroenterology and urology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

View all Michael M. Knott, M.D. devices

FDA 510(k) Submission Details - K971354

510(k) Number K971354 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 11, 1997
Decision Date November 19, 1997
Days to Decision 222 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
92d slower than avg
Panel avg: 130d · This submission: 222d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FEG Device Classification - Class 2, Special Controls

Product Code FEG Tube, Double Lumen For Intestinal Decompression And/or Intubation
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5980
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Gastroenterology & Urology devices follow this clearance model.

Regulatory Peers - FEG Tube, Double Lumen For Intestinal Decompression And/or Intubation

All 8
Devices cleared under the same product code (FEG) and FDA review panel - the closest regulatory comparables to K971354.
14Fr Colon Decompression Set, Macon Colon Decompression Set
K171619 · Cook Ireland, Ltd. · Aug 2017
MEDLINE ANTI-REFLUX VALVE
K132314 · Medline Industries, Inc. · Sep 2013
DAVOL NASOGASTRIC SUMP TUBE W/PREVENT FILTER
K960176 · C.R. Bard, Inc. · Jul 1996
ARGYLE SALEM SUMP TUBE ANTI-REFLUX VALVE INSERTION TRAY
K935781 · Sherwood Medical Co. · Jan 1995
LOPEZ VALVE WITH NG SUMP TUBE
K921104 · Icu Medical, Inc. · Oct 1992
WILSON-COOK COLON DECOMPRESSION SET
K900035 · Wilson-Cook Medical, Inc. · Mar 1990