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FDA 510(k)

NUCLEOTOME PROBE SET, MODEL 21200

K-Number: K040919 · 2004-06-01

ApplicantClarus Medical, LLC
Decision Date2004-06-01
Product CodeHRX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

NUCLEOTOME PROBE SET, MODEL 21200 is the device name listed in this FDA 510(k) record. The listed applicant is Clarus Medical, LLC. It received FDA 510(k) clearance on 2004-06-01 under 510(k) number K040919. The device is classified under product code HRX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NUCLEOTOME PROBE SET, MODEL 21200?

NUCLEOTOME PROBE SET, MODEL 21200 is a medical device that received FDA 510(k) clearance on 2004-06-01. The listed applicant is Clarus Medical, LLC. The 510(k) number is K040919.

When did NUCLEOTOME PROBE SET, MODEL 21200 receive FDA 510(k) clearance?

NUCLEOTOME PROBE SET, MODEL 21200 received FDA 510(k) clearance on 2004-06-01, under 510(k) number K040919.

Who is the listed applicant for NUCLEOTOME PROBE SET, MODEL 21200?

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

What is the FDA product code for NUCLEOTOME PROBE SET, MODEL 21200?

The FDA product code for NUCLEOTOME PROBE SET, MODEL 21200 is HRX.

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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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