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Inject-Snare

by Endovations

510(k) K942110

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 NumberK942110 Date13 Oct 1994ClearedStatusActive

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  • Withdrawn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.

The Inject-Snare is a flexible snare device designed for endoscopic retrieval and removal of foreign bodies, gallstones, or other obstructions within the gastrointestinal or urinary tract. It operates by capturing and securing objects via a loop mechanism, allowing safe extraction during minimally invasive procedures. This device is classified as a flexible snare under FDA regulations and is intended for use in gastroenterology and urology applications.

The Inject-Snare is supplied as a single-use, non-sterile device and must be sterilized prior to use, typically via ethylene oxide or autoclave methods. It is compatible with MRI environments and is available in various sizes as indicated by the associated registration numbers. Storage requires adherence to manufacturer guidelines to maintain device integrity. Its regulatory clearance under FDA 510(k) (K942110) confirms substantial equivalence to predicate devices, ensuring compliance with U.S. medical device standards.

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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 Inject-Snare designed for?

    The Inject-Snare is a flexible snare device specifically engineered for endoscopic retrieval of foreign bodies, gallstones, or obstructions within the gastrointestinal or urinary tract. Its loop mechanism allows clinicians to securely capture and extract these objects during minimally invasive procedures, ensuring safe removal while minimizing patient discomfort or risk.

  • How is the Inject-Snare supplied and prepared for use?

    The Inject-Snare is supplied as a single-use, non-sterile device. Before use, it must be sterilized using methods like ethylene oxide or autoclaving to ensure safety and efficacy. Always follow the manufacturer’s guidelines for sterilization to maintain device integrity and performance.

  • Is the Inject-Snare compatible with MRI environments?

    Yes, the Inject-Snare is designed to be compatible with MRI environments, making it suitable for use in procedures where imaging is required without interference. This ensures flexibility in clinical settings where both retrieval and diagnostic imaging are needed.

  • What sizes or models of the Inject-Snare are available?

    The Inject-Snare is available in multiple sizes, each identified by unique registration numbers (e.g., 3006546082, 3003782610, etc.). These variations allow clinicians to select the appropriate size based on the patient’s anatomy and the nature of the obstruction or foreign body being targeted.

  • How should the Inject-Snare be stored to maintain its integrity?

    The Inject-Snare must be stored according to the manufacturer’s guidelines to preserve its functionality and sterility (if pre-sterilized). Proper storage conditions prevent damage and ensure the device remains ready for use when needed, particularly before sterilization if supplied non-sterile.