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FDA 510(k)

da Vinci SP Advanced Access Port Kit (432701)

K-Number: K243582 · 2025-02-28

ApplicantIntuitive Surgical, Inc.
Decision Date2025-02-28
Product CodeNAY
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

da Vinci SP Advanced Access Port Kit (432701) is a medical device manufactured by Intuitive Surgical, Inc.. It received FDA 510(k) clearance on 2025-02-28 under approval number K243582. The device is classified under product code NAY. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the da Vinci SP Advanced Access Port Kit (432701)?

da Vinci SP Advanced Access Port Kit (432701) is a medical device that received FDA 510(k) clearance on 2025-02-28. It is manufactured by Intuitive Surgical, Inc.. The 510(k) number is K243582.

When was da Vinci SP Advanced Access Port Kit (432701) approved by the FDA?

da Vinci SP Advanced Access Port Kit (432701) received FDA 510(k) clearance on 2025-02-28, under approval number K243582.

What company makes da Vinci SP Advanced Access Port Kit (432701)?

da Vinci SP Advanced Access Port Kit (432701) is manufactured by Intuitive Surgical, Inc..

What is the FDA product code for da Vinci SP Advanced Access Port Kit (432701)?

The FDA product code for da Vinci SP Advanced Access Port Kit (432701) is NAY.

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Related PubMed Literature

PMID: 40965839 A multi-stakeholder perspective on medical devices for children and adolescents with type 1 diabetes: huge unmet needs for the smallest. Journal of pediatric endocrinology & metabolism : JPEM (2025)

Other Devices by Intuitive Surgical, Inc.

K162411da Vinci Xi 12 – 8 mm Reducer K153276da Vinci Xi Surgical System K161271da Vinci Xi Surgical System K152578da Vinci Surgical System, Model IS4000 K152448da Vinci Single-Site Instrument and Accessories K152421IS4000 Stapler 30 Instrument and Stapler 30 Reloads

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Related Devices (Code: NAY)

K162411da Vinci Xi 12 – 8 mm ReducerIntuitive Surgical, Inc. K153276da Vinci Xi Surgical SystemIntuitive Surgical, Inc. K161271da Vinci Xi Surgical SystemIntuitive Surgical, Inc. K152892da Vinci Xi Surgical SystemIntuitive Surgical K152578da Vinci Surgical System, Model IS4000Intuitive Surgical, Inc. K152448da Vinci Single-Site Instrument and AccessoriesIntuitive Surgical, Inc.

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.

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