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FDA 510(k)

HEPAFIX BIOPSY NEEDLE SET

K-Number: K813085 · 1981-11-20

ApplicantBurron Medical Products, Inc.
Decision Date1981-11-20
Product CodeKNW
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

HEPAFIX BIOPSY NEEDLE SET is the device name listed in this FDA 510(k) record. The listed applicant is Burron Medical Products, Inc.. It received FDA 510(k) clearance on 1981-11-20 under 510(k) number K813085. 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 HEPAFIX BIOPSY NEEDLE SET?

HEPAFIX BIOPSY NEEDLE SET is a medical device that received FDA 510(k) clearance on 1981-11-20. The listed applicant is Burron Medical Products, Inc.. The 510(k) number is K813085.

When did HEPAFIX BIOPSY NEEDLE SET receive FDA 510(k) clearance?

HEPAFIX BIOPSY NEEDLE SET received FDA 510(k) clearance on 1981-11-20, under 510(k) number K813085.

Who is the listed applicant for HEPAFIX BIOPSY NEEDLE SET?

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

What is the FDA product code for HEPAFIX BIOPSY NEEDLE SET?

The FDA product code for HEPAFIX BIOPSY NEEDLE SET is KNW.

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Other records listing Burron Medical Products, Inc. as applicant

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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

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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