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BMRI Soft Tissue Biopsy Needle

by Bio-Medical Resources, Inc.

510(k) K861959

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 NumberK861959 Date23 Sep 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  • Withdrawn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
KNW
Device Class
Class II
Regulation
21 CFR Part 876.1075
Advisory Committee
Gastroenterology, Urology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 25 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 BMRI Soft Tissue Biopsy Needle is a device designed for obtaining soft tissue biopsy specimens. It is substantially equivalent to a legally marketed predicate device as determined by FDA 510(k) clearance.

This device is supplied sterile and intended for single-use. It is used in clinical settings for percutaneous biopsy procedures and has received FDA 510(k) clearance under product code KNW, with clearance granted on September 23, 1986, under K861959.

Questions

AI-generated answers, 25 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 BMRI Soft Tissue Biopsy Needle used for?

    The BMRI Soft Tissue Biopsy Needle is designed for obtaining soft tissue biopsy specimens through percutaneous procedures in clinical settings, allowing clinicians to collect tissue samples for diagnostic evaluation.

  • Is the BMRI Soft Tissue Biopsy Needle sterile and intended for single-use or reuse?

    The device is supplied sterile and intended for single-use only, meaning it should be discarded after one procedure to prevent cross-contamination and ensure patient safety.

  • What regulatory clearance does the BMRI Soft Tissue Biopsy Needle have and when was it granted?

    The BMRI Soft Tissue Biopsy Needle received FDA 510(k) clearance on September 23, 1986, under K861959, with product code KNW, confirming its substantial equivalence to a legally marketed predicate device.