510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K163610Substantially Equivalent

PIEZOTOME M+, PIEZOTOME M+ Handpiece

Satalec-Acteon Group, Merignac, FR / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K163610 is the FDA 510(k) clearance record for PIEZOTOME M+, PIEZOTOME M+ Handpiece, a class II device, cleared for Satalec-Acteon Group on under FDA product code JDX (Instrument, Surgical, Sonic And Accessory/Attachment). FDA records list one 510(k) clearance for Satalec-Acteon Group. As of , FDA records show no recalls naming K163610.

Clearance record

Decision date
Received
(148 days to decision)
Product code
JDX Instrument, Surgical, Sonic And Accessory/Attachment
Regulation
21 CFR 888.4580
Device class
Class II
Review panel
Orthopedic
Applicant
Satalec-Acteon Group 17 Ave. Gustave Eiffel, Merignac, FR
510(k) summary
Summary PDF
Third party review
No

Clearances, product code JDX

Trailing 12 months

FDA records hold no clearances under product code JDX in the trailing twelve months.

FDA records show no clearances under product code JDX in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code JDX, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260