FDA.reportPublic FDA data

DISTALMOTION SA

Matched from indexed company URL: Distalmotion SA

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30331189643033118964DISTALMOTION SA1N2026-01-01Route de la Corniche 3B Epalinges Vaud CH 1066

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
07640184840134Dexter L6 Accessory tray - Dexter L6216-744-2602support@distalmotion.com
07640184840158Dexter L6 Handle Grip - Dexter L6216-744-2602support@distalmotion.com
07640184840172Dexter L6 Incision Pointer - Dexter L6216-744-2602support@distalmotion.com
07640184840196Dexter L6 Emergency Release Tool - Dexter L6216-744-2602support@distalmotion.com
07640184840219Dexter L6 Endoscope Cart - Dexter L6216-744-2602support@distalmotion.com
07640184840233Dexter Sterile Interface - Dexter L6 Sterile Interface216-744-2602support@distalmotion.com
07640184840417Dexter Bipolar Maryland Dissector - Dexter L6 Bipolar Maryland Dissector216-744-2602support@distalmotion.com
07640184840516Dexter L6 Robot - Dexter L6 - Patient Cart 1Dexter L6 - Patient Cart 2Dexter L6 - Surgeon Console216-744-2602support@distalmotion.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
3327751106327552K251197Dexter L6 SystemSDD2025-09-30
3327751852649408K233312SOLOASSIST IID / DEXTER ENDOSCOPE ARM (212499); ARTip solo (202426) + ARTip solo voice (202445); SOLOASSIST II (141364) + VOICE CONTROL (171894QZB2024-08-08

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
SDD12025-09-30
QZB12024-08-08

GUDID#