Cleared Traditional

8 mm Assist Cannula; 12 mm Assist Cannula

K251490 · Intuitive Surgical, Inc. · General & Plastic Surgery

Jul 2025

Decision

49d

Days

Class 2

Risk

About This 510(k) Submission

K251490 is an FDA 510(k) clearance for the 8 mm Assist Cannula; 12 mm Assist Cannula, a Laparoscope, General & Plastic Surgery (Class II — Special Controls, product code GCJ), submitted by Intuitive Surgical, Inc. (Suunyvale, US). The FDA issued a Cleared decision on July 2, 2025, 49 days after receiving the submission on May 14, 2025. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 876.1500.

Submission Details

510(k) Number	K251490 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 14, 2025
Decision Date	July 02, 2025
Days to Decision	49 days
Submission Type	Traditional
Review Panel	General & Plastic Surgery (SU)
Summary	Summary PDF

Device Classification

Product Code	GCJ — Laparoscope, General & Plastic Surgery
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 876.1500
Definition	Validated Reprocessing Instructions And Reprocessing Validation Data For This Device Type Must Be Included In A 510(k) Submission If The Device Is Reusable And Has Specific Design Features (please Refer To Table 2 Of 82 Fr 26807, Available At Https://www.gpo.gov/fdsys/pkg/fr-2017-06-09/pdf/2017-12007.pdf).