PIEZOTOME M+, PIEZOTOME M+ Handpiece
K-Number: K163610 · 2017-05-19
ApplicantSatalec-Acteon Group
Decision Date2017-05-19
Product CodeJDX
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
PIEZOTOME M+, PIEZOTOME M+ Handpiece is a medical device manufactured by Satalec-Acteon Group. It received FDA 510(k) clearance on 2017-05-19 under approval 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. It is manufactured by Satalec-Acteon Group. The 510(k) number is K163610.
When was PIEZOTOME M+, PIEZOTOME M+ Handpiece approved by the FDA?
PIEZOTOME M+, PIEZOTOME M+ Handpiece received FDA 510(k) clearance on 2017-05-19, under approval number K163610.
What company makes PIEZOTOME M+, PIEZOTOME M+ Handpiece?
PIEZOTOME M+, PIEZOTOME M+ Handpiece is manufactured by Satalec-Acteon Group.
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)
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.