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RENASYS Touch - RENASYS Y-Connector

by Smith & Nephew Medical Limited

510(k) K181822

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Source FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK181822 Date21 Mar 2019ClearedStatusActive

Official records

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA product code
OMP
Models / Variants
RENASYS Y-Connector
Device class
Class II
Regulation
21 CFR Part 878.4780
Advisory committee
General, Plastic Surgery
FDA decision
SESE Substantially Equivalent

Related clearances

cited in the FDA summary

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Cites

Cited by

Source: 510k-lineage (choiben314), CC BY 4.0

Overview

AI-generated summary, 19 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Renasys Touch; Renasys Y-Connector is a Negative Pressure Wound Therapy Powered Suction Pump designed for use with negative pressure wound therapy systems. It employs a software-controlled, electric motor-driven diaphragm vacuum pump to deliver controlled negative pressure (25–200 mmHg) to one or two wounds simultaneously via disposable containers, aiding in exudate removal and fluid management.

The device is intended for use with the Renasys Touch and Renasys Go systems, operating on mains power or internal battery. It is classified as a Class II medical device under FDA regulations (K181822) and is supplied as a reusable component paired with single-use disposable containers. No specific MRI safety or sterility details are provided in the data, though standard aseptic practices apply in clinical settings. The Y-Connector enables dual-wound therapy when paired with compatible systems.

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