Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

8043750

FEI Number

3002948288

Entity Name

DE SOUTTER MEDICAL LTD.

City/State/Country

ASTON CLINTON Buckinghamshire, GB

Establishment Address

HALTON BROOK BUSINESS PARK, WESTON ROAD, ASTON CLINTON Buckinghamshire HP22 5WF, GB

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

DE SOUTTER MEDICAL LTD. (Owner Number: 9003610)

Owner / Operator Contact Address

HALTON BROOK BUSINESS PARK, WESTON ROAD, ASTON CLINTON, GB-BKM HP22 5WF, GB

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Stericut Bur GD-113 DAVIES (R) GOLD SERIES DERMATOME GD-103 GS-102 RDX MBU SDX DBR MCU MCI ACZ MULTIDRIVE MODULAR MGX DCS DBN MBC DCA MBX MCZ DBK MBQ TDZ KDX DBZ ECV DBC MDX CDX MPZ DPC DIRECT DRIVE INSTRUMENT SYSTEM MULTIPLE HST DPZ D30 MPX EPV DPX CC4 CLEANCAST SAW SYSTEM CSB CC5 CC6 CSP T10 T20 PUMP KITS PULSE LAVAGE P10 P30 Irrigation Kits P20 PLX CC4 CC8 CLEAN CAST SAW SYSTEM CC7 CSB CSP CC5 CC6

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GFF	Bur, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4820	2023-02-17
GFD	Dermatome	General, Plastic Surgery	Class 1	878.4820	2002-09-07
GEY	Motor, Surgical Instrument, Ac-Powered	General, Plastic Surgery	Class 1	878.4820	2002-03-27
GET	Motor, Surgical Instrument, Pneumatic Powered	General, Plastic Surgery	Class 1	878.4820	2002-08-21
LGH	Instrument, Cast Removal, Ac-Powered	Orthopedic	Class 1	888.5960	2002-03-27
FQH	Lavage, Jet	General Hospital	Class 2	880.5475	2002-09-07
LGF	Component, Cast	Orthopedic	Class 1	888.5940	1995-06-28

Official Correspondent

MEHUL CHAUHAN

US Agent Details

Collin Metz Business: De Soutter Medical USA Inc Email: collin.metz@de-soutter.com Phone: (704) 6559040

Related Public Records

Same Entity

DE SOUTTER MEDICAL LTD.

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

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K905383	Micro Surgical Instruments Corp.	2710-000 OSCILLATING SAW, GENERAL ASSEMBLY	1991-06-18
K913369	Micro Surgical Instruments Corp.	MICRO-AIRE MODEL 2060	1991-11-01
K953432	Midas Rex Pneumatic Tools, Inc.	ROTATING, FIXED FOOTED, FIXED SHIELD ATTACHMENTS, DISSECTING TOOLS	1995-09-14
K213616	Becton, Dickinson and Company	BD Surgiphor Antimicrobial Irrigation System	2022-03-23

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 8043750. Last updated year: 2026. Please use registration number 8043750 when referencing this establishment in official correspondence.