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FDA 510(k)

K-C HEMOSTATIC BIOPSY SYSTEM

K-Number: K050135 · 2005-07-13

ApplicantBioengineering Consultants , Ltd.
Decision Date2005-07-13
Product CodeFCG
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

K-C HEMOSTATIC BIOPSY SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Bioengineering Consultants , Ltd.. It received FDA 510(k) clearance on 2005-07-13 under 510(k) number K050135. 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 K-C HEMOSTATIC BIOPSY SYSTEM?

K-C HEMOSTATIC BIOPSY SYSTEM is a medical device that received FDA 510(k) clearance on 2005-07-13. The listed applicant is Bioengineering Consultants , Ltd.. The 510(k) number is K050135.

When did K-C HEMOSTATIC BIOPSY SYSTEM receive FDA 510(k) clearance?

K-C HEMOSTATIC BIOPSY SYSTEM received FDA 510(k) clearance on 2005-07-13, under 510(k) number K050135.

Who is the listed applicant for K-C HEMOSTATIC BIOPSY SYSTEM?

The FDA 510(k) record lists Bioengineering Consultants , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for K-C HEMOSTATIC BIOPSY SYSTEM?

The FDA product code for K-C HEMOSTATIC BIOPSY SYSTEM 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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