VS3-IR
FDA 510(k) K183453 · Medtronic
510(k) numberK183453
Submission
- Device name
- VS3-IR
- Applicant
- Medtronic
Petach Tikva, Hamerkaz, IL - Received
- December 13, 2018
- Decision date
- March 4, 2019
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- OWN – Confocal Optical Imaging
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.1500
- Specialty
- Gastroenterology, Urology
Collection of light signals for visualization of cellular microstructures.
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Questions and answers
When was VS3-IR cleared by the FDA?
VS3-IR (K183453) received a 510(k) decision of Substantially Equivalent on March 4, 2019, 81 days after the submission was received.
What is the product code of K183453?
The FDA product code is OWN – Confocal Optical Imaging, a Class II (moderate risk) device regulated under 21 CFR 876.1500.