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FDA 510(k)

FULL CORE BIOPSY SYSTEM

K-Number: K111765 · 2011-09-06

ApplicantPromex Technologies, LLC
Decision Date2011-09-06
Product CodeKNW
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

FULL CORE BIOPSY SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Promex Technologies, LLC. It received FDA 510(k) clearance on 2011-09-06 under 510(k) number K111765. 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 FULL CORE BIOPSY SYSTEM?

FULL CORE BIOPSY SYSTEM is a medical device that received FDA 510(k) clearance on 2011-09-06. The listed applicant is Promex Technologies, LLC. The 510(k) number is K111765.

When did FULL CORE BIOPSY SYSTEM receive FDA 510(k) clearance?

FULL CORE BIOPSY SYSTEM received FDA 510(k) clearance on 2011-09-06, under 510(k) number K111765.

Who is the listed applicant for FULL CORE BIOPSY SYSTEM?

The FDA 510(k) record lists Promex Technologies, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FULL CORE BIOPSY SYSTEM?

The FDA product code for FULL CORE BIOPSY SYSTEM is KNW.

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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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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