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FDA 510(k)

BMRI SOFT TISSUE BIOPSY NEEDLE

K-Number: K861959 · 1986-09-23

ApplicantBio-Medical Resources, Inc.
Decision Date1986-09-23
Product CodeKNW
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

BMRI SOFT TISSUE BIOPSY NEEDLE is the device name listed in this FDA 510(k) record. The listed applicant is Bio-Medical Resources, Inc.. It received FDA 510(k) clearance on 1986-09-23 under 510(k) number K861959. The device is classified under product code KNW. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BMRI SOFT TISSUE BIOPSY NEEDLE?

BMRI SOFT TISSUE BIOPSY NEEDLE is a medical device that received FDA 510(k) clearance on 1986-09-23. The listed applicant is Bio-Medical Resources, Inc.. The 510(k) number is K861959.

When did BMRI SOFT TISSUE BIOPSY NEEDLE receive FDA 510(k) clearance?

BMRI SOFT TISSUE BIOPSY NEEDLE received FDA 510(k) clearance on 1986-09-23, under 510(k) number K861959.

Who is the listed applicant for BMRI SOFT TISSUE BIOPSY NEEDLE?

The FDA 510(k) record lists Bio-Medical Resources, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BMRI SOFT TISSUE BIOPSY NEEDLE?

The FDA product code for BMRI SOFT TISSUE BIOPSY NEEDLE is KNW.

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Related Devices (Code: KNW)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

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