USA Elite System Vaportrode Vaporization Electrode and Vaportome Resection Electrode
FDA 510(k) K973820 · Circon Corp.
510(k) numberK973820
Submission
- Device name
- USA Elite System Vaportrode Vaporization Electrode and Vaportome Resection Electrode
- Applicant
- Circon Corp.
Santa Barbara, CA, US - Received
- October 7, 1997
- Decision date
- May 12, 1998
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary 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 USA Elite System Vaportrode Vaporization Electrode and Vaportome Resection Electrode cleared by the FDA?
USA Elite System Vaportrode Vaporization Electrode and Vaportome Resection Electrode (K973820) received a 510(k) decision of Substantially Equivalent on May 12, 1998, 217 days after the submission was received.
What is the product code of K973820?
The FDA product code is FAS – Electrode, Electrosurgical, Active, Urological, a Class II (moderate risk) device regulated under 21 CFR 876.4300.