Singapore HSA registration DE0502797
Tenex Health TX ultrasonic surgical aspiration System
Singapore·CLASS C·Tenex Health, Inc·Registered February 21, 2019Device classification
- Device Class
- CLASS C
- Medical Speciality Area
- General & Plastic Surgery
Registration information
- Registration Number
- DE0502797
- Registration Date
- February 21, 2019
- Retention Due Date
- February 20, 2026
Product description
The Tenex Health TX System is an ultrasonic surgical aspirator that cuts and removes soft tissue. The indicated for use in surgical procedures where fragmentation, emulsification, and aspiration of soft tissue are desirable, including General, Orthopedic, Laparoscopic, Plastic and Reconstructive Surgery. It is designed to be used in conjunction with an ultrasound imaging device that will allow for visualization of the target tissue and surgical action under the skin during the surgery. It consists of a console, foot pedal, TX MicroTip, and inflation cuff. The console provides control over the three modes of operation including irrigation, aspiration, and cutting. The TX Microtip is used by the clinician to direct ultrasonic energy to the patient for cutting soft tissue, while simultaneously irrigating the target site and removing the waste. The TX MicroTip is supplied integral with the tube set, and are supplied sterile in a single-use, disposable package.
Product Owner
- Short Name
- Tenex Health, Inc
- Address
- 26902 Vista Terrace, Lake Forest, CA, 92630, UNITED STATES
Registrant
- Address
- 8 JALAN KILANG TIMOR, KEWALRAM HOUSE, #03-04A, SINGAPORE 159305
Importer
- Address
- 8 JALAN KILANG TIMOR, KEWALRAM HOUSE, #03-04A, SINGAPORE 159305
Model information
- Model Name(s)
- Fuse Set, 5x20, 250V, T5A Power Cord, 120V, USA TX System Console Steute Foot Pedal TX1 Procedure Pack TX Inflation Cuff TX2 Procedure Pack
- Model Identifier(s)
- 430-2215-002 430-4023-001 554-0000-000 554-0001-001 554-1003-002 554-1006-001 554-2003-002
About this record
Access comprehensive regulatory information for Tenex Health TX ultrasonic surgical aspiration System in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0502797 and owned by Tenex Health, Inc. The device was registered on February 21, 2019.
This page provides complete registration details including product owner information, registrant details, importer information, and regulatory compliance data from the official Singapore HSA medical device database. Pure Global AI offers free access to Singapore's complete medical device registry, helping global MedTech companies navigate HSA regulations efficiently.
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