Varisource Wright Vaginal Cuff Applicator for Varian Varisource Remote High Dose Rate Afterioader
FDA 510(k) K980601 · Varian Assoc., Inc.
510(k) numberK980601
Submission
- Device name
- Varisource Wright Vaginal Cuff Applicator for Varian Varisource Remote High Dose Rate Afterioader
- Applicant
- Varian Assoc., Inc.
Palo Alto, CA, US - Received
- February 17, 1998
- Decision date
- October 21, 1998
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Varisource Wright Vaginal Cuff Applicator for Varian Varisource Remote High Dose Rate Afterioader cleared by the FDA?
Varisource Wright Vaginal Cuff Applicator for Varian Varisource Remote High Dose Rate Afterioader (K980601) received a 510(k) decision of Substantially Equivalent on October 21, 1998, 246 days after the submission was received.
What is the product code of K980601?
The FDA product code is JAQ – System, Applicator, Radionuclide, Remote-Controlled, a Class II (moderate risk) device regulated under 21 CFR 892.5700.