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Van-Tec Deflecting Loop Retriever

by Van-Tec, Inc.

510(k) K860269

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 NumberK860269 Date25 Mar 1986ClearedStatusActive

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  • Withdrawn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
FFL
Device Class
Class II
Regulation
21 CFR Part 876.4680
Advisory Committee
Gastroenterology, Urology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 19 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 Van-Tec Deflecting Loop Retriever is a dislodger, stone, basket, ureteral, metal device used in gastroenterology and urology procedures. It is designed to retrieve stones or foreign bodies from the urinary tract via endoscopic access.

This device is supplied non-sterile and is intended for reusable use after appropriate cleaning and sterilization by the user. It is regulated as a Class II medical device under FDA 510(k) clearance K860269, with product code FFL and regulation number 876.4680.

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Questions

AI-generated answers, 19 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 Van-Tec Deflecting Loop Retriever used for?

    The Van-Tec Deflecting Loop Retriever is designed to retrieve stones or foreign bodies from the urinary tract via endoscopic access, and is used in gastroenterology and urology procedures as a dislodger, stone, basket, ureteral, metal device.

  • Is the Van-Tec Deflecting Loop Retriever supplied sterile or non-sterile, and is it intended for single-use or reuse?

    The device is supplied non-sterile and is intended for reusable use after appropriate cleaning and sterilization by the user, as stated in the device description.

  • What regulatory pathway was used for the Van-Tec Deflecting Loop Retriever, and what is its classification?

    The device is regulated as a Class II medical device under FDA 510(k) clearance K860269, with a traditional clearance type and substantially equivalent decision, based on the provided authorization and decision data.

  • What is the product code and regulation number for the Van-Tec Deflecting Loop Retriever?

    The device has product code FFL and is regulated under regulation number 876.4680, as specified in the device data fields.