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FDA 510(k)

FINESSE ULTRA BREAST BIOPSY SYSTEM DRIVER (BLUE, PINK)

K-Number: K103359 · 2010-12-27

ApplicantC.R. Bard, Inc.
Decision Date2010-12-27
Product CodeKNW
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

FINESSE ULTRA BREAST BIOPSY SYSTEM DRIVER (BLUE, PINK) is the device name listed in this FDA 510(k) record. The listed applicant is C.R. Bard, Inc.. It received FDA 510(k) clearance on 2010-12-27 under 510(k) number K103359. 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 FINESSE ULTRA BREAST BIOPSY SYSTEM DRIVER (BLUE, PINK)?

FINESSE ULTRA BREAST BIOPSY SYSTEM DRIVER (BLUE, PINK) is a medical device that received FDA 510(k) clearance on 2010-12-27. The listed applicant is C.R. Bard, Inc.. The 510(k) number is K103359.

When did FINESSE ULTRA BREAST BIOPSY SYSTEM DRIVER (BLUE, PINK) receive FDA 510(k) clearance?

FINESSE ULTRA BREAST BIOPSY SYSTEM DRIVER (BLUE, PINK) received FDA 510(k) clearance on 2010-12-27, under 510(k) number K103359.

Who is the listed applicant for FINESSE ULTRA BREAST BIOPSY SYSTEM DRIVER (BLUE, PINK)?

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

What is the FDA product code for FINESSE ULTRA BREAST BIOPSY SYSTEM DRIVER (BLUE, PINK)?

The FDA product code for FINESSE ULTRA BREAST BIOPSY SYSTEM DRIVER (BLUE, PINK) is KNW.

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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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