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DSNARE, MODEL 00711087

by United States Endoscopy Group, Inc. 510(k)

Active United States

510(k) K051637

Overview

The DSNARE, MODEL 00711087 is an instrument classified as a biopsy and suction device under product code FCK. It is a non-diathermic polypectomy snare designed for use in gastroenterology and urology procedures.

The device is supplied as a disposable (single-use) system and was cleared via the FDA 510(k) process under K051637 on October 31, 2005. It is intended for use in clinical settings where polypectomy and suction are required, with no indication of reusability, sterility, MRI safety, or specific storage conditions provided in the data.

AI-generated from registry data, 25 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK051637 Date31 Oct 2005ClearedStatusActive

Coverage

1 jurisdiction

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 6 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
FCK
Device Class
Class II
Regulation
21 CFR Part 876.1075
Advisory Committee
Gastroenterology, Urology
FDA Decision
SESE Substantially Equivalent

Other devices from United States Endoscopy Group, Inc.

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Questions

  • What is the DSNARE, Model 00711087 used for?

    The DSNARE, Model 00711087 is a non-diathermic polypectomy snare designed for use in gastroenterology and urology procedures where biopsy and suction are required, as indicated in its product classification under FCK.

  • Is the DSNARE, Model 00711087 reusable or single-use?

    The device is supplied as a disposable (single-use) system, meaning it is intended for one-time use only and not designed for reprocessing or reuse, based on the provided specifications.

  • How was the DSNARE, Model 00711087 cleared for market?

    The DSNARE, Model 00711087 was cleared via the FDA 510(k) process under submission number K051637, with a decision date of October 31, 2005, and classified as substantially equivalent to a predicate device.