Turbt-Rf Electrodes and Electrosurgical Devices
FDA 510(k) K050488 · Prosurg, Inc.
510(k) numberK050488
Submission
- Device name
- Turbt-Rf Electrodes and Electrosurgical Devices
- Applicant
- Prosurg, Inc.
San Jose, CA, US - Received
- February 25, 2005
- Decision date
- April 1, 2005
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- FAS – Electrode, Electrosurgical, Active, Urological
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.4300
- Specialty
- Gastroenterology, Urology
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Questions and answers
When was Turbt-Rf Electrodes and Electrosurgical Devices cleared by the FDA?
Turbt-Rf Electrodes and Electrosurgical Devices (K050488) received a 510(k) decision of Substantially Equivalent on April 1, 2005, 35 days after the submission was received.
What is the product code of K050488?
The FDA product code is FAS – Electrode, Electrosurgical, Active, Urological, a Class II (moderate risk) device regulated under 21 CFR 876.4300.