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FDA 510(k)

PIEZOTOME SOLO

K-Number: K112188 · 2012-02-03

ApplicantSatelec - Acteon, Inc.
Decision Date2012-02-03
Product CodeDZI
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

PIEZOTOME SOLO is the device name listed in this FDA 510(k) record. The listed applicant is Satelec - Acteon, Inc.. It received FDA 510(k) clearance on 2012-02-03 under 510(k) number K112188. The device is classified under product code DZI. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PIEZOTOME SOLO?

PIEZOTOME SOLO is a medical device that received FDA 510(k) clearance on 2012-02-03. The listed applicant is Satelec - Acteon, Inc.. The 510(k) number is K112188.

When did PIEZOTOME SOLO receive FDA 510(k) clearance?

PIEZOTOME SOLO received FDA 510(k) clearance on 2012-02-03, under 510(k) number K112188.

Who is the listed applicant for PIEZOTOME SOLO?

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

What is the FDA product code for PIEZOTOME SOLO?

The FDA product code for PIEZOTOME SOLO is DZI.

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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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