Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) 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 a medical device manufactured by Smith & Nephew Medical Limited. It received FDA 510(k) clearance on 2019-01-10 under approval 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. It is manufactured by Smith & Nephew Medical Limited. The 510(k) number is K181204.

When was RENASYS Y-Connector; RENASYS TOUCH approved by the FDA?

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

What company makes RENASYS Y-Connector; RENASYS TOUCH?

RENASYS Y-Connector; RENASYS TOUCH is manufactured by Smith & Nephew Medical Limited.

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 Devices by Smith & Nephew Medical Limited

K153723ACTICOAT Surgical Dressing K161289DURAFIBER Ag K172521PICO Single Use Negative Pressure Wound Therapy System K172519PICO Single Use Negative Pressure Wound Therapy System K163387PICO Single Use Negative Pressure Wound Therapy System K180698PICO 7 Single Use Negative Pressure Wound Therapy System

View all 19 devices →

Related Devices (Code: OMP)

K160487V.A.C. Rx4 Negative Pressure Wound Therapy (NPWT) SystemKci USA, Inc. K161128Invia Motion-Endure Negative Pressure Wound Therapy System, Invia Motion-7-120 Days Negative Pressure Wound Therapy System, Invia Motion Canister/Tubing Set 0.151, Invia Motion Carrying Case, Power SupplyMedela AG K150960WoundPro Negative Pressure Wound Therapy SystemPensar Medical, LLC K161935Avance Foam Dressing Kit - XLMolnlycke Health Care Us, LLC K161948Avance Gauze Dressing KitsMolnlycke Health Care Us, LLC K161797Avance Tubing, Avance Y-Connector, Avance ViewPadMolnlycke Health Care Us, LLC

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.

↑