Cleared Traditional

Standard Bougie, 38 Fr. (K210437) - FDA 510(k) Clearance

Class II Gastroenterology & Urology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K210437 · Standard Bariatrics · Gastroenterology & Urology device
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Jun 2021
Decision
137d
Days
Class 2
Risk

K210437 is an FDA 510(k) clearance for the Standard Bougie, 38 Fr.. Classified as Tubes, Gastrointestinal (and Accessories) (product code KNT), Class II - Special Controls.

Submitted by Standard Bariatrics (Cincinnati, US). The FDA issued a Cleared decision on June 29, 2021 after a review of 137 days - within the typical 510(k) review window.

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 Standard Bariatrics devices

Submission Details

510(k) Number K210437 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 12, 2021
Decision Date June 29, 2021
Days to Decision 137 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
7d slower than avg
Panel avg: 130d · This submission: 137d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KNT Tubes, Gastrointestinal (and Accessories)
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 - KNT Tubes, Gastrointestinal (and Accessories)

All 141
Devices cleared under the same product code (KNT) and FDA review panel - the closest regulatory comparables to K210437.
Avanos* CORTRAK* 2 Enteral Access System (EAS)
K220588 · Avanos Medical, Inc. · Apr 2022
Qora Stool Management Kit
K212444 · Cm Technologies, Inc. · Nov 2021
Standard Bougie, 38 Fr. and Hand Pump
K212728 · Standard Bariatrics · Sep 2021
Safety Trocar Cannula
K211072 · Boston Scientific Corporation · Apr 2021
Enteral Feeding Catheter
K202748 · Medcaptain Life Science Co., Ltd. · Apr 2021
ENvizion Medical ENvue ENvizion Medical Enteral Feeding Tube
K203133 · Envizion Medical , Ltd. · Mar 2021