Class Class II

Affirm 400 (K251286)

K251286 2026-01-21 Traditional
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Description

Affirm 400 by Digital Surgery Systems, Inc. (D.B.A True Digital Surgery), an FDA 510(k) cleared neurology device.

Regulatory Information

Device ClassClass Class II
510(k) NumberK251286
Clearance Date2026-01-21
Clearance TypeTraditional
Product CodeQFX
Regulation Number882.4950

Categories

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