FDA 510(k)

PIEZOTOME M+, PIEZOTOME M+ Handpiece

K-Number: K163610 · 2017-05-19

Decision Date2017-05-19

Product CodeJDX

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

PIEZOTOME M+, PIEZOTOME M+ Handpiece is the device name listed in this FDA 510(k) record. The listed applicant is Satalec-Acteon Group. It received FDA 510(k) clearance on 2017-05-19 under 510(k) number K163610. The device is classified under product code JDX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PIEZOTOME M+, PIEZOTOME M+ Handpiece?

PIEZOTOME M+, PIEZOTOME M+ Handpiece is a medical device that received FDA 510(k) clearance on 2017-05-19. The listed applicant is Satalec-Acteon Group. The 510(k) number is K163610.

When did PIEZOTOME M+, PIEZOTOME M+ Handpiece receive FDA 510(k) clearance?

PIEZOTOME M+, PIEZOTOME M+ Handpiece received FDA 510(k) clearance on 2017-05-19, under 510(k) number K163610.

Who is the listed applicant for PIEZOTOME M+, PIEZOTOME M+ Handpiece?

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

What is the FDA product code for PIEZOTOME M+, PIEZOTOME M+ Handpiece?

The FDA product code for PIEZOTOME M+, PIEZOTOME M+ Handpiece is JDX.

Related Devices (Code: JDX)

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.

K201274Ultrasonic Osteotomy Surgical SystemSmtp Technology Co., Ltd.K172464XD880A Ultrasonic Osteotomy Surgical SystemMorley Research Consortium K153743PIEZOSURGERY PLUSMectron S.P.A.

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.