Cleared Special

ReShape Calibration Tubes (K230131) - FDA 510(k) Clearance

Class II Gastroenterology & Urology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K230131 · Reshape Lifesciences · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2023
Decision
29d
Days
Class 2
Risk

K230131 is an FDA 510(k) clearance for the ReShape Calibration Tubes. Classified as Tubes, Gastrointestinal (and Accessories) (product code KNT), Class II - Special Controls.

Submitted by Reshape Lifesciences (San Clemente, US). The FDA issued a Cleared decision on February 15, 2023 after a review of 29 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Reshape Lifesciences devices

Submission Details

510(k) Number K230131 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 17, 2023
Decision Date February 15, 2023
Days to Decision 29 days
Submission Type Special
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
101d faster than avg
Panel avg: 130d · This submission: 29d
Pathway characteristics
Modification to existing cleared device.

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 142
Devices cleared under the same product code (KNT) and FDA review panel - the closest regulatory comparables to K230131.
AMT G-Tube Balloon Gastrostomy Feeding Device
K222846 · Applied Medical Technology, Inc. · Dec 2023
Entarik Feeding Tube System
K230206 · Gravitas Medical, Inc. · Mar 2023
Endolumik Fluorescence Guided Gastric Calibration Tube (FG Bougie)
K222880 · Endolumik, Inc. · Mar 2023
hygh-tec drainage
K221400 · Creative Balloons GmbH · Feb 2023
Standard Tapered Bougie, 38 Fr.
K222085 · Standard Bariatrics, Inc. · Oct 2022
DoubleChek DC-1001
K212316 · Nasogastric Feeding Solutions, Ltd. · Sep 2022