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Core-Snare

by Incore Co., Ltd.

510(k) K220846

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 NumberK220846 Date21 Nov 2022ClearedStatusActive

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  • Withdrawn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, 24 Sep 2026

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

The Core Snare is a flexible snare, a medical device used for the removal of tissues such as polyps during endoscopic procedures. It is a disposable, motor-operated device. The device is classified as a Snare, Flexible, with a product code of FDI. It falls under the medical specialty of Gastroenterology and Urology.

The Core Snare is supplied as a disposable device. It has been cleared by the FDA with a 510(k) number of K220846, classified as a Class II device with special controls, under regulation number 876.4300. The device is intended for single-use and is available in various configurations, although specific sizes are not detailed in the provided data.

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Questions

AI-generated answers, 24 Sep 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 Core Snare used for?

    The Core Snare is used for the removal of tissues such as polyps during endoscopic procedures in the medical specialties of Gastroenterology and Urology.

  • Is the Core Snare reusable?

    No, the Core Snare is intended for single-use and is supplied as a disposable device.

  • What regulatory clearance does the Core Snare have?

    The Core Snare has been cleared by the FDA with a 510(k) number of K220846, classified as a Class II device with special controls, under regulation number 876.4300.

  • What product code does the Core Snare have?

    The Core Snare has a product code of FDI, classified as a Snare, Flexible.