Cleared Traditional

Entarik Feeding Tube System (K230206) - FDA 510(k) Clearance

Also marketed or referenced as:
Entarik Feeding Tube

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

K230206 · Gravitas Medical, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2023
Decision
58d
Days
Class 2
Risk

K230206 is an FDA 510(k) clearance for the Entarik Feeding Tube System. Classified as Tubes, Gastrointestinal (and Accessories) (product code KNT), Class II - Special Controls.

Submitted by Gravitas Medical, Inc. (San Francisco, US). The FDA issued a Cleared decision on March 24, 2023 after a review of 58 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Gravitas Medical, Inc. devices

Submission Details

510(k) Number K230206 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 25, 2023
Decision Date March 24, 2023
Days to Decision 58 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
72d faster than avg
Panel avg: 130d · This submission: 58d
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 K230206.
Endolumik Gastric Calibration Tube M Series (EGCT36M)
K240069 · Endolumik · Feb 2024
ViSiGi 3D Gastric Sizing Tube
K234145 · Boehringer Laboratories · Jan 2024
AMT G-Tube Balloon Gastrostomy Feeding Device
K222846 · Applied Medical Technology, Inc. · Dec 2023
Endolumik Fluorescence Guided Gastric Calibration Tube (FG Bougie)
K222880 · Endolumik, Inc. · Mar 2023
ReShape Calibration Tubes
K230131 · Reshape Lifesciences · Feb 2023
hygh-tec drainage
K221400 · Creative Balloons GmbH · Feb 2023