Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3010034780

FEI Number

3010034780

Entity Name

Smith & Nephew, Inc.

City/State/Country

Lawrenceville, GA, US

Establishment Address

2225 Cedars Rd Ste A, Lawrenceville, GA 30043, US

Establishment Type(s)

Repack or Relabel Medical Device

Owner / Operator

SMITH & NEPHEW, INC. (Owner Number: 9002406)

Owner / Operator Contact Address

150 Minuteman Road, Andover, MA 01810, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Renasys Gel Adhesive SOLOSITE Conformable SOLOSITE Gel Renasys EZ PLUS Renasys Adhesive Gel Patch Renasys EZ CicaNet No-Sting Skin Prep Renasys F/-AB Abdominal Wound Dressing Kit ALLEVYN Modification to VersaTile 1 Wound V NPD 1000 NEGATIVE PRESSURE WOUND THERAPY SYSTEM EXU-DRY CONFORMANT 2 SKIN PREP VERSAJET SYSTEMS VersaJet II Hydrosurgery System Renasys Go Negative Pressure RENASYS AB Abdominial Kit with Soft Port No-Sting Skin-Prep Secura No-Sting Skin-Prep VERSAJET SYSTEMS IODOSORB GEL VISCOPASTE URI-KLEEN DETERGENT BANISH II LIQUID DEODORANT Tincture Benzoin RENASYS Touch Renasys -F Foam Dressing Kit Versatile 1 EZcare Wound Vacuum Sys VersaJet Hydrosurgery System AQUALERT DERMIVEX RENASYS Foam & gauze NPWT Wound Dressing Kits with Softport Flexigel PROFORE Wound Contact Layer DRYNET TRICOTEX

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	2013-02-04
OMP	Negative Pressure Wound Therapy Powered Suction Pump	General, Plastic Surgery	Class 2	878.4780	2010-08-17
KGT	Drape, Adhesive, Aerosol	General, Plastic Surgery	Class 1	878.4380	2012-08-31
OMP	Negative Pressure Wound Therapy Powered Suction Pump	General, Plastic Surgery	Class 2	878.4780	2008-12-08
MGP	Dressing, Wound And Burn, Occlusive	Unknown	Class U	N/A	2007-11-06
KMF	Bandage, Liquid	General Hospital	Class 1	880.5090	2007-11-06
FTL	Mesh, Surgical, Polymeric	General, Plastic Surgery	Class 2	878.3300	2010-09-20
FRO	Dressing, Wound, Drug	Unknown	Class U	N/A	2015-12-23
OMP	Negative Pressure Wound Therapy Powered Suction Pump	General, Plastic Surgery	Class 2	878.4780	2007-11-15
OMP	Negative Pressure Wound Therapy Powered Suction Pump	General, Plastic Surgery	Class 2	878.4780	2012-05-21
NAC	Dressing, Wound, Hydrophilic	General, Plastic Surgery	Class 1	878.4018	2017-01-23
NEC	Bandage, Liquid, Skin Protectant	General Hospital	Class 1	880.5090	2007-04-17
FQH	Lavage, Jet	General Hospital	Class 2	880.5475	2004-02-26
FQH	Lavage, Jet	General Hospital	Class 2	880.5475	2011-08-02
OMP	Negative Pressure Wound Therapy Powered Suction Pump	General, Plastic Surgery	Class 2	878.4780	2009-02-27
FTL	Mesh, Surgical, Polymeric	General, Plastic Surgery	Class 2	878.3300	2011-11-28
KMF	Bandage, Liquid	General Hospital	Class 1	880.5090	2012-07-16
FQH	Lavage, Jet	General Hospital	Class 2	880.5475	2004-02-26
KOZ	Beads, Hydrophilic, For Wound Exudate Absorption	General, Plastic Surgery	Class 1	878.4018	2006-01-26
FRO	Dressing, Wound, Drug	Unknown	Class U	N/A	2022-09-01
FON	Bag, Drainage, With Adhesive, Ostomy	Gastroenterology, Urology	Class 1	876.5900	1992-06-19
OMP	Negative Pressure Wound Therapy Powered Suction Pump	General, Plastic Surgery	Class 2	878.4780	2018-03-21
OMP	Negative Pressure Wound Therapy Powered Suction Pump	General, Plastic Surgery	Class 2	878.4780	2008-12-08
OMP	Negative Pressure Wound Therapy Powered Suction Pump	General, Plastic Surgery	Class 2	878.4780	2007-11-15
FQH	Lavage, Jet	General Hospital	Class 2	880.5475	2010-03-09
BYH	Drain, Tee (Water Trap)	Anesthesiology	Class 1	868.5995	2005-05-20
KGZ	Accessories, Catheter	General, Plastic Surgery	Class 1	878.4200	2005-05-20
BTA	Pump, Portable, Aspiration (Manual Or Powered)	General, Plastic Surgery	Class 2	878.4780	2011-07-07
OMP	Negative Pressure Wound Therapy Powered Suction Pump	General, Plastic Surgery	Class 2	878.4780	2011-07-07
KMF	Bandage, Liquid	General Hospital	Class 1	880.5090	2007-11-06
NAB	Gauze / Sponge,Nonresorbable For External Use	General, Plastic Surgery	Class 1	878.4014	2017-03-15

Official Correspondent

Beth Zis

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

SMITH & NEPHEW, INC.

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
K223112	Smith & Nephew, Inc.	MAVERICK Mini External Fixation System	2022-12-08
K072322	Smith & Nephew, Inc.	ULTRA FAST-FIX AND ULTRA FAST-FIX AB MENISCAL REPAIR SYSTEMS	2007-09-18
K953018	Ttl Medical	UNI-SITE	1995-09-08
K220540	Covidien	ProGrip Self-Gripping Polypropylene Mesh	2022-09-22
K150256	Argentum Medical	SILVERLON BURN CONTACT DRESSINGS	2015-04-30

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0001-2019	Smith & Nephew, Inc.	2	Journey BCS Knee CoCr Femoral Components, Catalog Numbers: 74021210, 74021211, 74021212, 74021213, 74021214, 74021215, 74021216, 74021217, 74021218, 74021219, 74021220, 74021221, 74021222, 74021223, 74021224, 74021225, 74021226, 74021227, 74021228, 74021229
Z-0002-2019	Smith & Nephew, Inc.	2	JOURNEY BCS OXINIUM Knee Femoral Components, Catalog Numbers: 74021110, 74021111, 74021112, 74021113, 74021114, 74021115, 74021116, 74021117, 74021118, 74021119, 74021120, 74021121, 74021122, 74021123, 74021124, 74021125, 74021126, 74021127, 74021128, 74021129, 74021130, 74021131, 74021132, 74021133, 74021134, 74021135, 74021136, 74021137, 74021138, 74021139, 74021140, 74021141, 74021142, 74021143, 74021144, 74021145, 74021146, 74021147, 74021148, 74021149
Z-0003-2019	Smith & Nephew, Inc.	2	JOURNEY BCS Knee Conventional Polyethylene Inserts: 74023111, 74023112, 74023113, 74023114, 74023115, 74023116, 74023117, 74023118, 74023121, 74023122, 74023123, 74023124, 74023125, 74023126, 74023127, 74023128, 74023131, 74023132, 74023133, 74023134, 74023135, 74023136, 74023137, 74023138, 74023141, 74023142, 74023143, 74023144, 74023145, 74023146, 74023147, 74023148, 74023211, 74023212, 74023213, 74023214, 74023215, 74023216, 74023217, 74023218, 74023221, 74023222, 74023223, 74023224, 74023225, 74023226, 74023227, 74023228, 74023231, 74023232, 74023233, 74023234, 74023235, 74023236, 74023237, 74023238, 74023241, 74023242, 74023243, 74023244, 74023245, 74023246, 74023247, 74023248, 74023251, 74023252, 74023253, 74023254, 74023255, 74023256, 74023257, 74023258, 74023261, 74023262, 74023263, 74023264, 74023265, 74023266, 74023267, 74023268, 74023271, 74023272, 74023273, 74023274, 74023275, 74023276, 74023277, 74023278, 74023281, 74023282, 74023283, 74023284, 74023285, 74023286, 74023287, 74023288, 74023311, 74023312, 74023313, 74023314, 74023315, 74023316, 74023317, 74023318, 74023321, 74023322, 74023323, 74023324, 74023325, 74023326, 74023327, 74023328, 74023331, 74023332, 74023333, 74023334, 74023335, 74023336, 74023337, 74023338, 74023341, 74023342, 74023343, 74023344, 74023345, 74023346, 74023347, 74023348, 74023411, 74023412, 74023413, 74023414, 74023415, 74023416, 74023417, 74023418, 74023421, 74023422, 74023423, 74023424, 74023425, 74023426, 74023427, 74023428, 74023431, 74023432, 74023433, 74023434, 74023435, 74023436, 74023437, 74023438, 74023441, 74023442, 74023443, 74023444, 74023445, 74023446, 74023447, 74023448, 74023451, 74023452, 74023453, 74023454, 74023455, 74023456, 74023457, 74023458, 74023461, 74023462, 74023463, 74023464, 74023465, 74023466, 74023467, 74023468, 74023471, 74023472, 74023473, 74023474, 74023475, 74023476, 74023477, 74023478, 74023481, 74023482, 74023483, 74023484, 74023485, 74023486, 74023487, 74023488, 74023648, 74203326
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 3010034780. Last updated year: 2026. Please use registration number 3010034780 when referencing this establishment in official correspondence.