FDA 510(k)

CASSI II ROTATIONAL CORE BIOPSY SYSTEM; CASSI QUADPOINT DISPOSABLE

K-Number: K123606 · 2013-03-01

ApplicantScion Medical Technologies, LLC

Decision Date2013-03-01

Product CodeKNW

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

CASSI II ROTATIONAL CORE BIOPSY SYSTEM; CASSI QUADPOINT DISPOSABLE is the device name listed in this FDA 510(k) record. The listed applicant is Scion Medical Technologies, LLC. It received FDA 510(k) clearance on 2013-03-01 under 510(k) number K123606. 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 QUADPOINT DISPOSABLE?

CASSI II ROTATIONAL CORE BIOPSY SYSTEM; CASSI QUADPOINT DISPOSABLE is a medical device that received FDA 510(k) clearance on 2013-03-01. The listed applicant is Scion Medical Technologies, LLC. The 510(k) number is K123606.

When did CASSI II ROTATIONAL CORE BIOPSY SYSTEM; CASSI QUADPOINT DISPOSABLE receive FDA 510(k) clearance?

CASSI II ROTATIONAL CORE BIOPSY SYSTEM; CASSI QUADPOINT DISPOSABLE received FDA 510(k) clearance on 2013-03-01, under 510(k) number K123606.

Who is the listed applicant for CASSI II ROTATIONAL CORE BIOPSY SYSTEM; CASSI QUADPOINT DISPOSABLE?

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

What is the FDA product code for CASSI II ROTATIONAL CORE BIOPSY SYSTEM; CASSI QUADPOINT DISPOSABLE?

The FDA product code for CASSI II ROTATIONAL CORE BIOPSY SYSTEM; CASSI QUADPOINT DISPOSABLE is KNW.

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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.