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FDA 510(k)

MAMMOTOME BIOPSY PROBE AND HOUSING (MAMMOTOME)

K-Number: K970565 · 1997-03-28

ApplicantBiopsys Medical, Inc.
Decision Date1997-03-28
Product CodeKNW
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

MAMMOTOME BIOPSY PROBE AND HOUSING (MAMMOTOME) is the device name listed in this FDA 510(k) record. The listed applicant is Biopsys Medical, Inc.. It received FDA 510(k) clearance on 1997-03-28 under 510(k) number K970565. 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 MAMMOTOME BIOPSY PROBE AND HOUSING (MAMMOTOME)?

MAMMOTOME BIOPSY PROBE AND HOUSING (MAMMOTOME) is a medical device that received FDA 510(k) clearance on 1997-03-28. The listed applicant is Biopsys Medical, Inc.. The 510(k) number is K970565.

When did MAMMOTOME BIOPSY PROBE AND HOUSING (MAMMOTOME) receive FDA 510(k) clearance?

MAMMOTOME BIOPSY PROBE AND HOUSING (MAMMOTOME) received FDA 510(k) clearance on 1997-03-28, under 510(k) number K970565.

Who is the listed applicant for MAMMOTOME BIOPSY PROBE AND HOUSING (MAMMOTOME)?

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

What is the FDA product code for MAMMOTOME BIOPSY PROBE AND HOUSING (MAMMOTOME)?

The FDA product code for MAMMOTOME BIOPSY PROBE AND HOUSING (MAMMOTOME) is KNW.

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Other records listing Biopsys Medical, Inc. as applicant

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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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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