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Brimfield Cannulated Magnetic Retriever

by Brimfield Scientific Instruments 510(k)

Active United States

510(k) K843135

Overview

This device is an Endoscopic Magnetic Retriever (FDA Product Code FCC), designed for the retrieval of foreign bodies or fragments within the gastrointestinal or urinary tract. It employs a cannulated, magnetically activated mechanism to locate and extract objects endoscopically, aiding in procedures for gastroenterology and urology.

The Brimfield Cannulated Magnetic Retriever is supplied as a reusable medical instrument, intended for use in controlled clinical settings. It was granted FDA 510(k) clearance under Subpart B—Diagnostic Devices (21 CFR 876.1500) in 1984, classified as a Class II device. No specific sterility or MRI safety details are provided in the regulatory data.

AI-generated from registry data, 19 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 NumberK843135 Date26 Sep 1984ClearedStatusActive

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
FCC
Device Class
Class II
Regulation
21 CFR Part 876.1500
Advisory Committee
Gastroenterology, Urology
FDA Decision
SESE Substantially Equivalent

Other devices from Brimfield Scientific Instruments

Questions

  • What types of medical procedures is the Brimfield Cannulated Magnetic Retriever primarily used for?

    The Brimfield Cannulated Magnetic Retriever is designed for endoscopic retrieval of foreign bodies or fragments in the gastrointestinal or urinary tracts. It is specifically intended for use in gastroenterology and urology procedures, such as removing swallowed objects or urinary tract stones that cannot be passed naturally.

  • Is the Brimfield Cannulated Magnetic Retriever a single-use or reusable device?

    The Brimfield Cannulated Magnetic Retriever is explicitly described as a reusable medical instrument. It is intended for use in controlled clinical settings, meaning it is meant to be cleaned, sterilized, and reused for multiple procedures rather than being discarded after a single use.

  • What regulatory pathway was followed for the FDA clearance of this device?

    The Brimfield Cannulated Magnetic Retriever received FDA 510(k) clearance under Subpart B—Diagnostic Devices (21 CFR 876.1500) in 1984. The clearance was granted as substantially equivalent to a predicate device, following a traditional review process through the Gastroenterology and Urology (GU) advisory committee.

  • Are there any specific details about the sterility or MRI safety of this device provided in the regulatory data?

    The regulatory data for the Brimfield Cannulated Magnetic Retriever does not include specific details about sterility or MRI safety. If these factors are critical for your use case, additional information would need to be obtained directly from the manufacturer.