510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K251197Substantially Equivalent

Dexter L6 System

Distalmotion SA, Epalinges, CH / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K251197 is the FDA 510(k) clearance record for Dexter L6 System, a class II device, cleared for Distalmotion SA on under FDA product code SDD (Electromechanical Surgical System Wherein The Surgeon Annd The User Interface Can Be In The Sterile Field). FDA's definition for product code SDD reads: "An electromechanical surgical system with transient sterile field presence of both surgeon and primary control interface is a software-controlled electromechanical system with fully positionable patient/device interfaces which allows a...". FDA records list 5 510(k) clearances for Distalmotion SA, from to . As of , FDA records show no recalls naming K251197.

Clearance record

Decision date
Received
(166 days to decision)
Product code
SDD Electromechanical Surgical System Wherein The Surgeon Annd The User Interface Can Be In The Sterile Field
Regulation
21 CFR 878.4965
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Distalmotion SA Rte. De La Corniche 3b, Epalinges, CH
510(k) summary
Summary PDF
Third party review
No

Clearances, product code SDD

Trailing 12 months
2 clearances under product code SDD in the twelve months to October 2026, June 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code SDD, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20261
July 20260
August 20261
September 20260
October 20260