Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

8043484

FEI Number

3002808194

Entity Name

Smith & Nephew Medical Ltd

City/State/Country

HULL East Riding of Yorkshire, GB

Establishment Address

101 Hessle Road, HULL East Riding of Yorkshire HU3 2BN, GB

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

SMITH AND NEPHEW MEDICAL LTD. (Owner Number: 9001952)

Owner / Operator Contact Address

101 HESSLE RD., --, HULL, GB-NOTA HU3 2BN, GB

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K905069

PMA Number

N/A

All Registered Proprietary Names

INTRASITE Conformable INTRASITE Gel SOLOSITE Gel SOLOSITE Conformable ACTICOAT EXFIX ACTICOAT Site ACTICOAT Moisture Control ACTICOAT Post Op RENASYS Wound+ Dressing Kit with AIRLOCK Technology BIOBRANE Glove BIOBRANE Dressing ALLEVYN Ag+ ACTICOAT FLEX 7 ACTICOAT FLEX 3 ACTICOAT FLEX PROGUIDE Wound Contact Layer ALLEVYN Thin CUTINOVA Hydro ALLEVYN Gentle ALLEVYN Gentle Border ALLEVYN Tracheostomy ALLEVYN Adhesive ALLEVYN Non Adhesive ALLEVYN LIFE Non-Bordered RENASYS Adhesive Gel Patch REPLICARE REPLICARE Thin REPLICARE Ultra ALLEVYN Gentle Border Lite ALLEVYN Gentle Border Sacrum ALLEVYN Gentle Border Multisite ALLEVYN Gentle Border Heel ALLEVYN Life ALLEVYN Complete Care RENASYS AB Abdominal dressing kit with soft port device Unisolve Adhesive Remover Remove Adhesive Remover RENASYS-WF White foam NPWT Dressing IODOFLEX pads CUTICERIN VERSAJET II Hydrosurgery System console VERSAJET II Footswitch VERSAJET II Exact handpiece 45 deg / 8 mm VERSAJET II Plus handpiece 45 deg / 14 mm VERSAJET II Exact handpiece 45 deg / 14 mm VERSAJET II Plus handpiece 45 deg / 8 mm VERSAJET II Exact handpiece 15 deg / 14 mm VERSAJET II Plus handpiece 15 deg / 14 mm ALLEVYN Ag Adhesive ALLEVYN Ag Non Adhesive ALLEVYN Ag Gentle Border ALLEVYN Ag Dressing LEUKOSTRIP S LEUKOSTRIP COVERSTRIP IODOSORB Gel RENASYS F Foam Dressing Kit with Soft Port Foam wound dressing RENASYS G Sterile Gauze Dressing Kit with Soft Port Antimicrobial gauze RENASYS Soft Port RENASYS EZ Max 800ml S-Canister without solidifier RENASYS EZ Plus/EZ Max 800ml S - Canister RENASYS EZ MAX pump RENASYS EZ Max Quick Reference Guide Antimicrobial gauze roll RENASYS EZ Plus/Max 250 ml Canister SKIN-PREP NO-STING SKIN-PREP NOVIX Primer+Cleanser RENASYS G Gauze Dressing Kits with Soft Port TRICOTEX PROFORE WOUND CONTACT LAYER OPSITE ACTICOAT Surgical Renasys-F XL Foam Dressing Kit With Soft Port Renasys XL Transparent Film Dressing RENASYS TOUCH PICO 14 Single Use Negative Pressure Wound Therapy System PICO 7Y Single Use Negative Pressure Wound Therapy System PICO 7 Single Use Negative Pressure Wound Therapy System CICA CARE IODOFLEX Paste TINCTURE OF BENZOIN BANISH II LIQUID DEODORANT URI-KLEEN DETERGENT LEAF Patient Monitoring System LEAF Patient Monitoring System Next Generation RENASYS GO Canister 300ml RENASYS GO Power supply RENASYS GO Pump RENASYS GO Canister 750ml RENASYS GO Odor filter RENASYS GO clinician manual RENASYS GO Carry Strap RENASYS GO Home healthcare user manual RENASYS GO Rubber Feet RENASYS GO Carry Case RENASYS GO 'O' ring RENASYS GO Quick reference guide ALLEVYN LIFE ALLEVYN Gentle Border Sacrum ALLEVYN Gentle Border Multisite ALLEVYN Gentle Border ALLEVYN Gentle Border Heel ALLEVYN Complete Care PICO 14 Single Use Negative Pressure Wound Therapy System ACTICOAT IODOSORB Gel

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
NAE	Dressing, Wound, Hydrogel Without Drug And/Or Biologic	General, Plastic Surgery	Class 1	878.4022	2003-10-16
FRO	Dressing, Wound, Drug	Unknown	Class U	N/A	2007-12-21
OMP	Negative Pressure Wound Therapy Powered Suction Pump	General, Plastic Surgery	Class 2	878.4780	2025-09-18
FRO	Dressing, Wound, Drug	Unknown	Class U	N/A	2025-01-14
KGN	Wound Dressing With Animal-Derived Material(S)	Unknown	Class U	N/A	2025-01-14
FRO	Dressing, Wound, Drug	Unknown	Class U	N/A	2024-04-24
FRO	Dressing, Wound, Drug	Unknown	Class U	N/A	2009-07-28
NAD	Dressing, Wound, Occlusive	General, Plastic Surgery	Class 1	878.4020	2003-10-16
OMP	Negative Pressure Wound Therapy Powered Suction Pump	General, Plastic Surgery	Class 2	878.4780	2017-01-30
FTL	Mesh, Surgical, Polymeric	General, Plastic Surgery	Class 2	878.3300	2017-01-30
KOX	Solvent, Adhesive Tape	General, Plastic Surgery	Class 1	878.4730	2015-09-20
OMP	Negative Pressure Wound Therapy Powered Suction Pump	General, Plastic Surgery	Class 2	878.4780	2023-02-21
KMF	Bandage, Liquid	General Hospital	Class 1	880.5090	2015-11-04
FRO	Dressing, Wound, Drug	Unknown	Class U	N/A	2007-12-21
FQH	Lavage, Jet	General Hospital	Class 2	880.5475	2016-04-29
FRO	Dressing, Wound, Drug	Unknown	Class U	N/A	2007-12-19
MZR	Topical Approximation System	General Hospital	Class 1	880.5240	2011-10-21
OMP	Negative Pressure Wound Therapy Powered Suction Pump	General, Plastic Surgery	Class 2	878.4780	2018-08-22
FRO	Dressing, Wound, Drug	Unknown	Class U	N/A	2020-07-28
OMP	Negative Pressure Wound Therapy Powered Suction Pump	General, Plastic Surgery	Class 2	878.4780	2025-06-16
OMP	Negative Pressure Wound Therapy Powered Suction Pump	General, Plastic Surgery	Class 2	878.4780	2016-05-16
NEC	Bandage, Liquid, Skin Protectant	General Hospital	Class 1	880.5090	2015-08-26
OMP	Negative Pressure Wound Therapy Powered Suction Pump	General, Plastic Surgery	Class 2	878.4780	2017-06-02
NAB	Gauze / Sponge,Nonresorbable For External Use	General, Plastic Surgery	Class 1	878.4014	1995-12-26
PUI	Drape, Surgical, Exempt	General, Plastic Surgery	Class 2	878.4370	2020-07-28
FRO	Dressing, Wound, Drug	Unknown	Class U	N/A	2016-11-09
OMP	Negative Pressure Wound Therapy Powered Suction Pump	General, Plastic Surgery	Class 2	878.4780	2022-06-22
OMP	Negative Pressure Wound Therapy Powered Suction Pump	General, Plastic Surgery	Class 2	878.4780	2019-06-20
QFC	Negative Pressure Wound Therapy Device For Reduction Of Wound Complications	General, Plastic Surgery	Class 2	878.4783	2022-04-06
MDA	Elastomer, Silicone, For Scar Management	General, Plastic Surgery	Class 1	878.4025	1995-12-26
FRO	Dressing, Wound, Drug	Unknown	Class U	N/A	2020-07-28
FON	Bag, Drainage, With Adhesive, Ostomy	Gastroenterology, Urology	Class 1	876.5900	2015-10-21
OMP	Negative Pressure Wound Therapy Powered Suction Pump	General, Plastic Surgery	Class 2	878.4780	2021-02-24
KMI	Monitor, Bed Patient	General Hospital	Class 1	880.2400	2022-02-16
OMP	Negative Pressure Wound Therapy Powered Suction Pump	General, Plastic Surgery	Class 2	878.4780	2016-11-09
FMP	Protector, Skin Pressure	General Hospital	Class 1	880.6450	2016-03-16
OMP	Negative Pressure Wound Therapy Powered Suction Pump	General, Plastic Surgery	Class 2	878.4780	2019-12-18
FRO	Dressing, Wound, Drug	Unknown	Class U	N/A	2007-12-21
KOZ	Beads, Hydrophilic, For Wound Exudate Absorption	General, Plastic Surgery	Class 1	878.4018	2015-11-04

Official Correspondent

Samantha Neilson

US Agent Details

Arti Arvind Email: Aarathi.Arvind@smith-nephew.com Phone: (978) 7491000

Related Public Records

Same Entity

SMITH AND NEPHEW 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
K150256	Argentum Medical	SILVERLON BURN CONTACT DRESSINGS	2015-04-30
K112888	Kensey Nash Corporation	MESO WOUND MATRIX	2012-02-10
K040211	Collagen Matrix, Inc.	MODIFICATION TO: COLLAGEN TOPICAL WOUND DRESSING	2004-02-27
K881936	Iberhospitex, S.A.	OPER-FILM-ADHESIVE MEMBRANE	1988-08-31
K220540	Covidien	ProGrip Self-Gripping Polypropylene Mesh	2022-09-22

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0003-06	B. Braun Medical, Inc.	U	D-Stat Dry Hemostatic Bandage. The product is an adhesive bandage.
Z-0038-2025	3M Company Health Care Business 3m Center	U	3M Tegaderm CHG, Chlorhexidine Gluconate I.V. Securement Dressing, REF 1658R
Z-0009-2013	Accuro Medical Product LLC	2	Wound Pro Apex Negative Pressure Wound Therapy Powered Suction Pump; Accuro Medical Products LLC, 2854 Hitchcock Ave, Downers Grove, IL 60515; part number 84635400182, sold inside the Apex Negative Wound Therapy system, part number 84635400181 Promotes wound healing through drainage and removal of infectious material and other fluids from the wound site using continuous and/or intermittent negative pressure. Types of wounds indicated include diabetic/neuropathic ulcers, pressure ulcers, chronic wounds, acute wounds and dehisced wounds.
Z-0039-2015	Smith & Nephew, Inc.	2	RENASYS EZ/ RENASYS EZ Plus 250 mL canister with Solidifier Product Usage: RENASYS EZ and RENASYS EZ Plus Canisters are used for the collection of exudate removed from wounds being treated by negative pressure wound therapy (NPWT).
Z-0040-2015	Smith & Nephew, Inc.	2	RENASYS EZ/ RENASYS EZ Plus 800 mL canister with Solidifier Product Usage: RENASYS EZ and RENASYS EZ Plus Canisters are used for the collection of exudate removed from wounds being treated by negative pressure wound therapy (NPWT).

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 8043484. Last updated year: 2026. Please use registration number 8043484 when referencing this establishment in official correspondence.