8 mm Assist Cannula; 12 mm Assist Cannula
K-Number: K251490 · 2025-07-02
ApplicantIntuitive Surgical, Inc.
Decision Date2025-07-02
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent
Device Summary
8 mm Assist Cannula; 12 mm Assist Cannula is a medical device manufactured by Intuitive Surgical, Inc.. It received FDA 510(k) clearance on 2025-07-02 under approval number K251490. The device is classified under product code GCJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the 8 mm Assist Cannula; 12 mm Assist Cannula?
8 mm Assist Cannula; 12 mm Assist Cannula is a medical device that received FDA 510(k) clearance on 2025-07-02. It is manufactured by Intuitive Surgical, Inc.. The 510(k) number is K251490.
When was 8 mm Assist Cannula; 12 mm Assist Cannula approved by the FDA?
8 mm Assist Cannula; 12 mm Assist Cannula received FDA 510(k) clearance on 2025-07-02, under approval number K251490.
What company makes 8 mm Assist Cannula; 12 mm Assist Cannula?
8 mm Assist Cannula; 12 mm Assist Cannula is manufactured by Intuitive Surgical, Inc..
What is the FDA product code for 8 mm Assist Cannula; 12 mm Assist Cannula?
The FDA product code for 8 mm Assist Cannula; 12 mm Assist Cannula is GCJ.
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.