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FDA 510(k)

COAXIAL BIOPSY NEEDLE

K-Number: K936194 · 1994-03-22

ApplicantBard Gynecology and Radiology
Decision Date1994-03-22
Product CodeFCG
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

COAXIAL BIOPSY NEEDLE is the device name listed in this FDA 510(k) record. The listed applicant is Bard Gynecology and Radiology. It received FDA 510(k) clearance on 1994-03-22 under 510(k) number K936194. The device is classified under product code FCG. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COAXIAL BIOPSY NEEDLE?

COAXIAL BIOPSY NEEDLE is a medical device that received FDA 510(k) clearance on 1994-03-22. The listed applicant is Bard Gynecology and Radiology. The 510(k) number is K936194.

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

COAXIAL BIOPSY NEEDLE received FDA 510(k) clearance on 1994-03-22, under 510(k) number K936194.

Who is the listed applicant for COAXIAL BIOPSY NEEDLE?

The FDA 510(k) record lists Bard Gynecology and Radiology as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for COAXIAL BIOPSY NEEDLE?

The FDA product code for COAXIAL BIOPSY NEEDLE is FCG.

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Related Devices (Code: FCG)

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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