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510(k) K163610

PIEZOTOME M+, PIEZOTOME M+ Handpiece by Satalec-Acteon Group — Product Code JDX

K163610 is an FDA 510(k) premarket notification submitted by Satalec-Acteon Group for the device "PIEZOTOME M+, PIEZOTOME M+ Handpiece". The FDA issued a decision of Substantially Equivalent on May 19, 2017. The device falls under product code JDX (Instrument, Surgical, Sonic And Accessory/Attachment), a Class II device regulated under 21 CFR 888.4580.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 19, 2017
Date Received
December 22, 2016
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Instrument, Surgical, Sonic And Accessory/Attachment
Device Class
Class II
Regulation Number
888.4580
Review Panel
OR
Submission Type

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  • K132848 — PIEZOSURGERY FLEX (November 29, 2013)
  • K100410 — PIEZOELECTRIC SYSTEM (April 28, 2010)
  • K093805 — OSCAR 3 (February 19, 2010)
  • K083284 — PIEZOSURGERY MEDICAL (April 8, 2009)
  • K083830 — OSCAR BONE RESECTOR (March 20, 2009)
  • K072961 — LOTUS ULTRASONIC SYSTEM FOR CEMENTED IMPLANT EXTRACTION (USCIX) (December 19, 2007)
  • K051053 — OSCAR, MODEL OE3000DB (July 21, 2005)

FDA data resources