Cleared Traditional

Affirm 800

K243077 · Digital Surgery Systems, Inc. (D.B.A True Digital Surgery) · Neurology

Jun 2025

Decision

270d

Days

Class 2

Risk

About This 510(k) Submission

K243077 is an FDA 510(k) clearance for the Affirm 800, a System, X-ray, Angiographic (Class II — Special Controls, product code IZI), submitted by Digital Surgery Systems, Inc. (D.B.A True Digital Surgery) (Goleta, US). The FDA issued a Cleared decision on June 27, 2025, 270 days after receiving the submission on September 30, 2024. This device falls under the Neurology review panel. Regulated under 21 CFR 892.1600.

Submission Details

510(k) Number	K243077 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 30, 2024
Decision Date	June 27, 2025
Days to Decision	270 days
Submission Type	Traditional
Review Panel	Neurology (NE)
Summary	Summary PDF