Gold Anchor
FDA 510(k) K201117 · Naslund Medical AB
510(k) numberK201117
Submission
- Device name
- Gold Anchor
- Applicant
- Naslund Medical AB
Huddinge, SE - Received
- April 27, 2020
- Decision date
- June 11, 2020
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Gold Anchor cleared by the FDA?
Gold Anchor (K201117) received a 510(k) decision of Substantially Equivalent on June 11, 2020, 45 days after the submission was received.
What is the product code of K201117?
The FDA product code is IYE – Accelerator, Linear, Medical, a Class II (moderate risk) device regulated under 21 CFR 892.5050.