Affirm 400
K-Number: K251286 · 2026-01-21
Decision Date2026-01-21
Product CodeQFX
Advisory CommitteeNE
DecisionSubstantially Equivalent
Device Summary
Affirm 400 is a medical device manufactured by Digital Surgery Systems, Inc. (D.B.A True Digital Surgery). It received FDA 510(k) clearance on 2026-01-21 under approval number K251286. The device is classified under product code QFX. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Affirm 400?
Affirm 400 is a medical device that received FDA 510(k) clearance on 2026-01-21. It is manufactured by Digital Surgery Systems, Inc. (D.B.A True Digital Surgery). The 510(k) number is K251286.
When was Affirm 400 approved by the FDA?
Affirm 400 received FDA 510(k) clearance on 2026-01-21, under approval number K251286.
What company makes Affirm 400?
Affirm 400 is manufactured by Digital Surgery Systems, Inc. (D.B.A True Digital Surgery).
What is the FDA product code for Affirm 400?
The FDA product code for Affirm 400 is QFX.
Other Devices by Digital Surgery Systems, Inc. (D.B.A True Digital Surgery)
Related Devices (Code: QFX)
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.