Cleared Traditional

SP Endoscope, 0? (430600)

K250786 · Intuitive Surgical, Inc. · General & Plastic Surgery

May 2025

Decision

60d

Days

Class 2

Risk

About This 510(k) Submission

K250786 is an FDA 510(k) clearance for the SP Endoscope, 0? (430600), 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 May 13, 2025, 60 days after receiving the submission on March 14, 2025. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 876.1500.

Submission Details

510(k) Number	K250786 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 14, 2025
Decision Date	May 13, 2025
Days to Decision	60 days
Submission Type	Traditional
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).