Evap-Electrodes Types 8423, 8427, 8410 & 8413 Electrosurgical Vaporization of Soft Tissue
FDA 510(k) K953983 · Richard Wolf Medical Instruments Corp.
510(k) numberK953983
Submission
- Device name
- Evap-Electrodes Types 8423, 8427, 8410 & 8413 Electrosurgical Vaporization of Soft Tissue
- Applicant
- Richard Wolf Medical Instruments Corp.
Vernon Hills, IL, US - Received
- August 23, 1995
- Decision date
- October 2, 1996
- 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 Evap-Electrodes Types 8423, 8427, 8410 & 8413 Electrosurgical Vaporization of Soft Tissue cleared by the FDA?
Evap-Electrodes Types 8423, 8427, 8410 & 8413 Electrosurgical Vaporization of Soft Tissue (K953983) received a 510(k) decision of Substantially Equivalent on October 2, 1996, 406 days after the submission was received.
What is the product code of K953983?
The FDA product code is FAS – Electrode, Electrosurgical, Active, Urological, a Class II (moderate risk) device regulated under 21 CFR 876.4300.