BioZorb Marker GOLD / LP Marker GOLD
FDA 510(k) K171467 · Focal Therapeutics
510(k) numberK171467
Submission
- Device name
- BioZorb Marker GOLD / LP Marker GOLD
- Applicant
- Focal Therapeutics
Sunnyvale, CA, US - Received
- May 18, 2017
- Decision date
- November 9, 2017
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was BioZorb Marker GOLD / LP Marker GOLD cleared by the FDA?
BioZorb Marker GOLD / LP Marker GOLD (K171467) received a 510(k) decision of Substantially Equivalent on November 9, 2017, 175 days after the submission was received.
What is the product code of K171467?
The FDA product code is IYE – Accelerator, Linear, Medical, a Class II (moderate risk) device regulated under 21 CFR 892.5050.