Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9611194

FEI Number

3002808293

Entity Name

SWANN MORTON, LTD.

City/State/Country

SHEFFIELD, GB

Establishment Address

OWLERTON GREEN, SHEFFIELD --, GB

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

SWANN MORTON, LTD. (Owner Number: 9003320)

Owner / Operator Contact Address

OWLERTON GREEN, --, SHEFFIELD, GB-NOTA --, GB

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Arrow Sklar Cincinnati Surgical Swann-Morton Propper DeRoyal Swann-Morton Spectra Swann-Morton Propper Cincinnati Surgical Surgipath DeRoyal Swann-Morton Cincinnati Surgical Swann-Morton Swann-Morton Propper Sklar Surgipath DeRoyal Swann-Morton Cincinnati Surgical Leica Swann-Morton

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GDX	Scalpel, One-Piece	General, Plastic Surgery	Class 1	878.4800	1991-08-01
GDZ	Handle, Scalpel	General, Plastic Surgery	Class 1	878.4800	1991-08-01
FZT	Cutter, Surgical	General, Plastic Surgery	Class 1	878.4800	2005-05-04
GES	Blade, Scalpel	General, Plastic Surgery	Class 1	878.4800	1991-08-01
FZW	Expander, Surgical, Skin Graft	General, Plastic Surgery	Class 1	878.4800	2005-05-04

Official Correspondent

No official correspondent registered.

US Agent Details

KEVIN WALLS Business: REGULATORY INSIGHT, INC. Email: kevin@reginsight.com Phone: (720) 9625412

Related Public Records

Same Entity

SWANN MORTON, LTD.

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3008812251	Swann-Morton(Services) Limited	Owlerton Green Sheffield, GB

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0039-2018	Teleflex Medical	1	Pilling Knife Handles: a) REF 352950 b) REF 352953 c) REF 352951 d) REF 352957 e) REF 352952 : Reusable surgical knife handles, which are intended for use with blades which are inserted into a slot in the handle.
Z-0012-2008	Becton Dickinson & Company	1	Shelf Pack: Bard-Parker Rib-Back Carbon Steel no.11, surgical blade. Unit Package: Contents of unopened or undamaged package guaranteed sterile; After use place product in a puncture resistant container and dispose properly. Becton Dickinson Becton Dickinson Acute Care Franklin Lakes, NJ 07417
Z-0013-2008	Becton Dickinson & Company	1	Shelf Pack: Bard-Parker Rib-Back Stainless Steel no.11, surgical blade. Unit Package: Contents of unopened or undamaged package guaranteed sterile; After use place product in a puncture resistant container and dispose properly. Becton Dickinson Becton Dickinson Acute Care Franklin Lakes, NJ 07417

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3005675811	QSUM BIOPSY DISPOSABLES LLC	Pequot Lakes, MN, US
9611283	DIMEDA INSTRUMENTE GMBH	TUTTLINGEN Baden-Wurttemberg, DE
3004050971	VINCENT MEDICAL (DONG GUAN) MANUFACTURING CO., LTD.	Dong Guan City Guangdong, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9611194. Last updated year: 2026. Please use registration number 9611194 when referencing this establishment in official correspondence.