Solace Therapeutics, Inc.
United StatesFDA applicant, unverified
- Devices
- 4
What Solace Therapeutics, Inc. makes
Solace Therapeutics, Inc. manufactures disposable urethral sheaths and cystoscopic sheaths designed to reduce infection risk during urological procedures. Their product line includes flexible sheaths for urethral access and rigid cystoscopes with angled viewing options (0°, 30°, and 70°) for bladder examinations.
These devices are classified as Class II under FDA regulations and are authorised via the 510(k) pathway. The company’s products are listed in the FDA’s 510(k) database, reflecting their compliance with U.S. medical device regulations. The manufacturer is based in the United States.
Catalogue
Guardian Urethral Sheath Ref K141252
Regimes: 510(k) Registry: 510(k)Vesair Cystoscopic Sheath Ref K162356
Regimes: 510(k) Registry: 510(k)Guardian Urethral Sheath Ref K131803
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Solace Therapeutics, Inc. have in the registry?
The registry currently lists 4 devices for Solace Therapeutics, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Solace Therapeutics, Inc.'s devices?
Among its 4 most recently registered devices, Solace Therapeutics, Inc. has devices listed in FDA 510(k) (4 devices).
What risk classes do Solace Therapeutics, Inc.'s devices fall under?
Among its 4 most recently registered devices, the classes recorded for Solace Therapeutics, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Solace Therapeutics, Inc. in the registry?
The most recently registered devices listed for Solace Therapeutics, Inc. include GUARDIAN URETHRAL SHEATH, Vesair Cystoscopic Sheath and Vesair 0 degree Cystoscope, Vesair 30 degree Long Cystoscope, Vesair 70 degree Long Cystoscope, Vesair 30 degree Cystoscope, Vesair 70 degree Cystoscope.