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FDA 510(k)

RENASYS TOUCH Negative Pressure Wound Therapy, RENASYS TOUCH Canisters, RENASYS TOUCH Carry Bag, Carry Strap, RENASYS Y-Connector, RENASYS TOUCH IV Pole/Bed Clamp, RENASYS TOUCH Class 2 Power Supply

K-Number: K153209 · 2016-08-04

ApplicantSmith & Nephew Medical, Ltd.
Decision Date2016-08-04
Product CodeOMP
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

RENASYS TOUCH Negative Pressure Wound Therapy, RENASYS TOUCH Canisters, RENASYS TOUCH Carry Bag, Carry Strap, RENASYS Y-Connector, RENASYS TOUCH IV Pole/Bed Clamp, RENASYS TOUCH Class 2 Power Supply is the device name listed in this FDA 510(k) record. The listed applicant is Smith & Nephew Medical, Ltd.. It received FDA 510(k) clearance on 2016-08-04 under 510(k) number K153209. The device is classified under product code OMP. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RENASYS TOUCH Negative Pressure Wound Therapy, RENASYS TOUCH Canisters, RENASYS TOUCH Carry Bag, Carry Strap, RENASYS Y-Connector, RENASYS TOUCH IV Pole/Bed Clamp, RENASYS TOUCH Class 2 Power Supply?

RENASYS TOUCH Negative Pressure Wound Therapy, RENASYS TOUCH Canisters, RENASYS TOUCH Carry Bag, Carry Strap, RENASYS Y-Connector, RENASYS TOUCH IV Pole/Bed Clamp, RENASYS TOUCH Class 2 Power Supply is a medical device that received FDA 510(k) clearance on 2016-08-04. The listed applicant is Smith & Nephew Medical, Ltd.. The 510(k) number is K153209.

When did RENASYS TOUCH Negative Pressure Wound Therapy, RENASYS TOUCH Canisters, RENASYS TOUCH Carry Bag, Carry Strap, RENASYS Y-Connector, RENASYS TOUCH IV Pole/Bed Clamp, RENASYS TOUCH Class 2 Power Supply receive FDA 510(k) clearance?

RENASYS TOUCH Negative Pressure Wound Therapy, RENASYS TOUCH Canisters, RENASYS TOUCH Carry Bag, Carry Strap, RENASYS Y-Connector, RENASYS TOUCH IV Pole/Bed Clamp, RENASYS TOUCH Class 2 Power Supply received FDA 510(k) clearance on 2016-08-04, under 510(k) number K153209.

Who is the listed applicant for RENASYS TOUCH Negative Pressure Wound Therapy, RENASYS TOUCH Canisters, RENASYS TOUCH Carry Bag, Carry Strap, RENASYS Y-Connector, RENASYS TOUCH IV Pole/Bed Clamp, RENASYS TOUCH Class 2 Power Supply?

The FDA 510(k) record lists Smith & Nephew Medical, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for RENASYS TOUCH Negative Pressure Wound Therapy, RENASYS TOUCH Canisters, RENASYS TOUCH Carry Bag, Carry Strap, RENASYS Y-Connector, RENASYS TOUCH IV Pole/Bed Clamp, RENASYS TOUCH Class 2 Power Supply?

The FDA product code for RENASYS TOUCH Negative Pressure Wound Therapy, RENASYS TOUCH Canisters, RENASYS TOUCH Carry Bag, Carry Strap, RENASYS Y-Connector, RENASYS TOUCH IV Pole/Bed Clamp, RENASYS TOUCH Class 2 Power Supply is OMP.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT04042259Delayed Primary Closure Using Negative Pressure Wound TherapyACTIVE_NOT_RECRUITINGNCT04618406The Effect of Negative Pressure Wound Therapy on Wound Healing in Major Amputations of the Lower LimbCOMPLETEDNCT04955730NPWT in Patients Undergoing Surgical Procedures for Management of GI MalignanciesCOMPLETEDNCT05598398NPWTi on Closure of Chronic Pressure SoresRECRUITINGNCT05615844Antibiotic Cement Bead Pouch Versus Negative Pressure Wound TherapyRECRUITINGNCT05977816PROPEL-2: Prophylactic Negative Pressure Wound Therapy in Laparotomy WoundsACTIVE_NOT_RECRUITING

Other records listing Smith & Nephew Medical, Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260646RENASYS EDGE (66803126)K251826RENASYS WOUND+ Dressing Kit with AIRLOCK TechnologyK243576RENASYS Foam Wound Dressing Kit with AIRLOCK Technology and Soft Port; RENASYS Gauze Wound Dressing Kit with AIRLOCK Technology and Soft PortK242146BIOBRANE Temporary Wound Dressing; BIOBRANE GloveK231939Renasys EdgeK223526ALLEVYN Ag+ Border Antimicrobial Silicone Gel Adhesive Composite Hydrocellular Foam Dressing, ALLEVYN Ag+ Border Sacrum Antimicrobial Silicone Gel Adhesive Composite Hydrocellular Foam Dressing, ALLEVYN Ag+ Surgical Antimicrobial Silicone Gel Adhesive Composite Hydrocellular Foam Dressing

View all 28 devices →

Related Devices (Code: OMP)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253263ConvaVAC™ Negative Pressure Wound Therapy SystemConvatec Limited, Gdc BuildingK253199CURASYS 2 (EMDN0003)CG Bio Co., Ltd.K260646RENASYS EDGE (66803126)Smith & Nephew Medical, Ltd.K261291Nisus NPWT Canister 500-mL (CPC-500)Cork MedicalK254019Wound Geni NPWT SystemBechtel Medical, Inc.K253429Genadyne ASTRA NPWTGenadyne Biotechnologies, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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