Temperature Sensor Probe (ABL-18TP20)
FDA 510(k) K240784 · Varian Medical Systems, Inc.
510(k) numberK240784
Submission
- Device name
- Temperature Sensor Probe (ABL-18TP20)
- Applicant
- Varian Medical Systems, Inc.
Palo Alto, CA, US - Received
- March 21, 2024
- Decision date
- May 29, 2024
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- NEY – System, Ablation, Microwave And Accessories
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.4400
- Specialty
- General, Plastic Surgery
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Questions and answers
When was Temperature Sensor Probe (ABL-18TP20) cleared by the FDA?
Temperature Sensor Probe (ABL-18TP20) (K240784) received a 510(k) decision of Substantially Equivalent on May 29, 2024, 69 days after the submission was received.
What is the product code of K240784?
The FDA product code is NEY – System, Ablation, Microwave And Accessories, a Class II (moderate risk) device regulated under 21 CFR 878.4400.