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FDA 510(k)

MICROMARK CLIP

K-Number: K970817 · 1997-09-11

ApplicantBiopsys Medical, Inc.
Decision Date1997-09-11
Product CodeGDW
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

MICROMARK CLIP 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 1997-09-11 under 510(k) number K970817. The device is classified under product code GDW. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MICROMARK CLIP?

MICROMARK CLIP is a medical device that received FDA 510(k) clearance on 1997-09-11. The listed applicant is Biopsys Medical, Inc.. The 510(k) number is K970817.

When did MICROMARK CLIP receive FDA 510(k) clearance?

MICROMARK CLIP received FDA 510(k) clearance on 1997-09-11, under 510(k) number K970817.

Who is the listed applicant for MICROMARK CLIP?

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 MICROMARK CLIP?

The FDA product code for MICROMARK CLIP is GDW.

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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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