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FDA 510(k)

SURE CORE BIOPSY KIT

K-Number: K963813 · 1997-03-20

ApplicantInterventional Concepts, Inc.
Decision Date1997-03-20
Product CodeKNW
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

SURE CORE BIOPSY KIT is the device name listed in this FDA 510(k) record. The listed applicant is Interventional Concepts, Inc.. It received FDA 510(k) clearance on 1997-03-20 under 510(k) number K963813. 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 SURE CORE BIOPSY KIT?

SURE CORE BIOPSY KIT is a medical device that received FDA 510(k) clearance on 1997-03-20. The listed applicant is Interventional Concepts, Inc.. The 510(k) number is K963813.

When did SURE CORE BIOPSY KIT receive FDA 510(k) clearance?

SURE CORE BIOPSY KIT received FDA 510(k) clearance on 1997-03-20, under 510(k) number K963813.

Who is the listed applicant for SURE CORE BIOPSY KIT?

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

What is the FDA product code for SURE CORE BIOPSY KIT?

The FDA product code for SURE CORE BIOPSY KIT 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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