Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

RENASYS Y-Connector; RENASYS TOUCH

K-Number: K181204 · 2019-01-10

ApplicantSmith & Nephew Medical Limited
Decision Date2019-01-10
Product CodeOMP
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

RENASYS Y-Connector; RENASYS TOUCH is the device name listed in this FDA 510(k) record. The listed applicant is Smith & Nephew Medical Limited. It received FDA 510(k) clearance on 2019-01-10 under 510(k) number K181204. 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 Y-Connector; RENASYS TOUCH?

RENASYS Y-Connector; RENASYS TOUCH is a medical device that received FDA 510(k) clearance on 2019-01-10. The listed applicant is Smith & Nephew Medical Limited. The 510(k) number is K181204.

When did RENASYS Y-Connector; RENASYS TOUCH receive FDA 510(k) clearance?

RENASYS Y-Connector; RENASYS TOUCH received FDA 510(k) clearance on 2019-01-10, under 510(k) number K181204.

Who is the listed applicant for RENASYS Y-Connector; RENASYS TOUCH?

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

What is the FDA product code for RENASYS Y-Connector; RENASYS TOUCH?

The FDA product code for RENASYS Y-Connector; RENASYS TOUCH is OMP.

Other records listing Smith & Nephew Medical Limited 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.

↑