Cleared Special

da Vinci SP Firefly Imaging System

K252350 · Intuitive Surgical, Inc. · General & Plastic Surgery

Aug 2025

Decision

30d

Days

Class 2

Risk

About This 510(k) Submission

K252350 is an FDA 510(k) clearance for the da Vinci SP Firefly Imaging System, a System, Surgical, Computer Controlled Instrument (Class II — Special Controls, product code NAY), submitted by Intuitive Surgical, Inc. (Suunyvale, US). The FDA issued a Cleared decision on August 28, 2025, 30 days after receiving the submission on July 29, 2025. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 876.1500.

Submission Details

510(k) Number	K252350 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 29, 2025
Decision Date	August 28, 2025
Days to Decision	30 days
Submission Type	Special
Review Panel	General & Plastic Surgery (SU)
Summary	Summary PDF

Device Classification

Product Code	NAY — System, Surgical, Computer Controlled Instrument
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 876.1500
Definition	If The Device Is Reusable, Validated Reprocessing Instructions And Reprocessing Validation Data For This Device Type Must Be Included In A 510(k) Submission (82 Fr 26807, Available At Https://www.gpo.gov/fdsys/pkg/fr-2017-06-09/pdf/2017-12007.pdf).