Affirm 800
FDA 510(k) K243077 · Digital Surgery Systems, Inc. (D.B.A True Digital Surgery)
510(k) numberK243077
Submission
- Device name
- Affirm 800
- Applicant
- Digital Surgery Systems, Inc. (D.B.A True Digital Surgery)
Goleta, CA, US - Received
- September 30, 2024
- Decision date
- June 27, 2025
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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More from Aesculap, Inc.
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| K251286 | Affirm 400QFX · Traditional | 01/21/2026SE |
Questions and answers
When was Affirm 800 cleared by the FDA?
Affirm 800 (K243077) received a 510(k) decision of Substantially Equivalent on June 27, 2025, 270 days after the submission was received.
What is the product code of K243077?
The FDA product code is IZI – System, X-Ray, Angiographic, a Class II (moderate risk) device regulated under 21 CFR 892.1600.