RENASYS Touch - RENASYS Touch
by Smith & Nephew Medical Limited
510(k) K181822
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK181822 | Date21 Mar 2019 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- OMP
- Models / Variants
- RENASYS Touch
- Device class
- Class II
- Regulation
- 21 CFR Part 878.4780
- Advisory committee
- General, Plastic Surgery
- FDA decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 19 Sep 2026
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.
Other devices from Smith & Nephew Medical, Ltd.
Questions
AI-generated answers, 19 Sep 2026
What is the primary purpose of the RENASYS Touch and RENASYS Y-Connector in wound care?
The RENASYS Touch and RENASYS Y-Connector are designed for negative pressure wound therapy (NPWT), which helps manage exudate and fluid in wounds. The device uses a software-controlled, electric motor-driven diaphragm pump to deliver controlled negative pressure (ranging from 25 to 200 mmHg) to one or two wounds simultaneously. This aids in wound healing by promoting granulation tissue formation and reducing excess fluid buildup. The Y-Connector specifically allows dual-wound therapy when paired with compatible systems.
How is the RENASYS Touch device powered, and what are its key operational modes?
The RENASYS Touch operates using two power sources: mains electricity for continuous use and an internal battery for portability. It is designed to work with the Renasys Touch and Renasys Go systems, delivering consistent negative pressure therapy for wound management. The device is reusable, while the disposable containers (which interface with the pump) are intended for single-use, ensuring hygiene and compliance with clinical standards.
Are there specific size or model variations for the RENASYS Touch, and how does the Y-Connector integrate with it?
The provided data does not specify individual size or model variations for the RENASYS Touch itself, but it is classified under product code OMP for negative pressure wound therapy pumps. The RENASYS Y-Connector is a complementary component that enables dual-wound therapy when paired with compatible Renasys systems. This means it allows simultaneous treatment of two wounds by branching the suction pathway, though the exact connector dimensions or compatibility details are not detailed in the data.
What are the key considerations for storage and handling of the RENASYS Touch and its disposables?
The RENASYS Touch itself is a reusable device, so it should be stored in a clean, dry environment per manufacturer guidelines to maintain functionality and hygiene. The disposable containers (which interface with the pump) are intended for single-use only and must be handled with standard aseptic practices to prevent contamination. While the data does not specify MRI safety or sterility certifications, clinical settings should follow standard protocols for NPWT disposables to ensure patient safety.