Cleared Traditional

Affirm 400

K251286 · Digital Surgery Systems, Inc. (D.B.A True Digital Surgery) · Neurology
Jan 2026
Decision
271d
Days
Class 2
Risk

About This 510(k) Submission

K251286 is an FDA 510(k) clearance for the Affirm 400, a Diagnostic Neurosurgical Microscope Filter (Class II — Special Controls, product code QFX), submitted by Digital Surgery Systems, Inc. (D.B.A True Digital Surgery) (Goleta, US). The FDA issued a Cleared decision on January 21, 2026, 271 days after receiving the submission on April 25, 2025. This device falls under the Neurology review panel. Regulated under 21 CFR 882.4950.

Submission Details

510(k) Number K251286 FDA.gov
FDA Decision Cleared SESE
Date Received April 25, 2025
Decision Date January 21, 2026
Days to Decision 271 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF

Device Classification

Product Code QFX — Diagnostic Neurosurgical Microscope Filter
Device Class Class II — Special Controls
CFR Regulation 21 CFR 882.4950
Definition A Diagnostic Neurosurgical Microscope Filter Is A Device Intended For Use During Neurosurgery To Visualize Fluorescence And Enhance Visualization Of Tissue Associated With A Specific Disease Or Condition.