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RescueNet

by Endochoice, Inc.

510(k) K152580

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK152580 Date3 Nov 2015ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 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  • Withdrawn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
FDI
Device Class
Class II
Regulation
21 CFR Part 876.4300
Advisory Committee
Gastroenterology, Urology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

RescueNet is a flexible snare device used for the retrieval of foreign bodies, tissue fragments, and polyps from the gastrointestinal (GI) tract. It is classified as a Class II medical device under regulation number 876.4300 and product code FDI.

The device was cleared through the FDA 510(k) process under K152580 with a traditional submission, receiving a substantially equivalent determination on November 3, 2015. It is manufactured by Endochoice, Inc. and is intended for use in gastroenterology and urology procedures.

Other devices from Endochoice, Inc.

See all devices from Endochoice, Inc. →

Questions

AI-generated answers, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the RescueNet device used for?

    RescueNet is a flexible snare device designed for the retrieval of foreign bodies, tissue fragments, and polyps from the gastrointestinal (GI) tract. It is used during gastroenterology and urology procedures to capture and remove abnormal tissue or objects that cannot be passed naturally, enabling minimally invasive intervention.

  • How is the RescueNet device supplied and is it reusable?

    The RescueNet device is supplied as a single-use, sterile flexible snare intended for one-time use only. It is not designed for reprocessing or reuse due to risks of material degradation, contamination, and compromised retrieval performance, which could endanger patient safety.

  • What regulatory pathway was used for RescueNet’s market authorization?

    RescueNet received market authorization through the FDA 510(k) process under submission number K152580, with a traditional clearance pathway. It was determined to be substantially equivalent to a predicate device on November 3, 2015, and is classified as a Class II medical device under regulation 876.4300 with product code FDI.