Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3033118964

FEI Number

3033118964

Entity Name

DISTALMOTION SA

City/State/Country

Epalinges Vaud, CH

Establishment Address

Route de la Corniche 3B, Epalinges Vaud 1066, CH

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility,Export Device to the United States But Perform No Other Operation on Device

Owner / Operator

Distalmotion SA (Owner Number: 10091399)

Owner / Operator Contact Address

Route de la Corniche 3B, Epalinges, CH-VD 1066, CH

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K251197

PMA Number

N/A

All Registered Proprietary Names

DEXTER ENDOSCOPE ARM Dexter L6 Accessory Tray Dexter L6 Sterile Interface Dexter L6 Monopolar Scissors Dexter L6 Needle Holder Dexter L6 Monopolar Hook Dexter L6 Incision Pointer Dexter L6 Robot Dexter L6 Bipolar Maryland Dissector Dexter L6 Emergency Release Tool Dexter L6 System Dexter L6 Bipolar Johann Grasper Dexter L6 Handle Grip Dexter L6 Endoscope Cart

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
QZB	Software Controlled Endoscope And Instrument Holder	Gastroenterology, Urology	Class 2	876.1500	2024-11-05
SDD	Electromechanical Surgical System Wherein The Surgeon Annd The User Interface Can Be In The Sterile Field	General, Plastic Surgery	Class 2	878.4965	2025-11-28

Official Correspondent

No official correspondent registered.

US Agent Details

Mindy McCann Business: Qserve Group US Inc. Email: USagent@qservegroup.com Phone: (424) 2718169

Related Public Records

Same Entity

Distalmotion SA

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3033118964. Last updated year: 2026. Please use registration number 3033118964 when referencing this establishment in official correspondence.