Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3016170849

FEI Number

3016170849

Entity Name

MOSAIC SURGICAL

City/State/Country

High Wycombe Buckinghamshire, GB

Establishment Address

Unit 9 York Way, High Wycombe Buckinghamshire HP12 3PY, GB

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Mosaic Surgical Ltd (Owner Number: 10062084)

Owner / Operator Contact Address

Unit 9 York Way, High Wycombe, GB-BKM HP12 3PY, GB

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Galaxy II Galaxy II Galaxy II

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FFO	Retractor, Self-Retaining	Gastroenterology, Urology	Class 1	876.4730	2020-01-31
KAL	Retractor, Ent	Ear, Nose, Throat	Class 1	874.4420	2023-02-23
GAD	Retractor	General, Plastic Surgery	Class 1	878.4800	2019-12-17

Official Correspondent

Rianne Mahanta

US Agent Details

Stephan Toupin Business: Dawa Medical Email: stoupin@dawamedical.com Phone: (786) 7311159

Related Public Records

Same Entity

Mosaic Surgical 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
K922626	Andronic Devices, Ltd.	ADEPT INSTRUMENT POSITIONING ACCESSORY	1992-10-19
K820290	The Anspach Effort, Inc.	SELF RETAINING RETRACTOR FOR HAND SURG	1982-03-05
K760422	Cutter Laboratories, Inc.	SURGICAL RETRACTOR	1976-08-23

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0031-2014	Aesculap, Inc.	1	UNITRAC Pneumatic Retraction Arm. A support arm used to hold surgical instruments during surgical procedures.

Similar Registrations

Registration Number	Establishment Name	Location
3032747418	HEXAMED PVT LTD	Sialkot Punjab, PK
9710524	ULTIMATE MEDICAL PRODUCTS LTD.	SHARJAH Ash Shariqah, AE
3010829427	SWANTIA MEDICAL PRIVATE LIMITED	Sialkot Punjab, PK
9614945	ROMINGER MEDIZINTECHNIK GMBH	SEITINGEN-OBERFLACHT Baden-Wurttemberg, DE
3009718267	DIVERSITY CORPORATION FZE	Sharjah Ash Shariqah, AE

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3016170849. Last updated year: 2026. Please use registration number 3016170849 when referencing this establishment in official correspondence.