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FDA 510(k)

CASSI II Rotational Core Biopsy System

K-Number: K161234 · 2016-08-03

ApplicantScion Medical Technologies, LLC
Decision Date2016-08-03
Product CodeKNW
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

CASSI II Rotational Core Biopsy System is a medical device manufactured by Scion Medical Technologies, LLC. It received FDA 510(k) clearance on 2016-08-03 under approval number K161234. 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 CASSI II Rotational Core Biopsy System?

CASSI II Rotational Core Biopsy System is a medical device that received FDA 510(k) clearance on 2016-08-03. It is manufactured by Scion Medical Technologies, LLC. The 510(k) number is K161234.

When was CASSI II Rotational Core Biopsy System approved by the FDA?

CASSI II Rotational Core Biopsy System received FDA 510(k) clearance on 2016-08-03, under approval number K161234.

What company makes CASSI II Rotational Core Biopsy System?

CASSI II Rotational Core Biopsy System is manufactured by Scion Medical Technologies, LLC.

What is the FDA product code for CASSI II Rotational Core Biopsy System?

The FDA product code for CASSI II Rotational Core Biopsy System is KNW.

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Related Devices (Code: 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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