FDA 510(k)

SP Endoscope, 0° (430600)

K-Number: K250786 · 2025-05-13

Decision Date2025-05-13

Product CodeNAY

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

SP Endoscope, 0° (430600) is a medical device manufactured by Intuitive Surgical, Inc.. It received FDA 510(k) clearance on 2025-05-13 under approval number K250786. 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 SP Endoscope, 0° (430600)?

SP Endoscope, 0° (430600) is a medical device that received FDA 510(k) clearance on 2025-05-13. It is manufactured by Intuitive Surgical, Inc.. The 510(k) number is K250786.

When was SP Endoscope, 0° (430600) approved by the FDA?

SP Endoscope, 0° (430600) received FDA 510(k) clearance on 2025-05-13, under approval number K250786.

What company makes SP Endoscope, 0° (430600)?

SP Endoscope, 0° (430600) is manufactured by Intuitive Surgical, Inc..

What is the FDA product code for SP Endoscope, 0° (430600)?

The FDA product code for SP Endoscope, 0° (430600) is NAY.

Other Devices by Intuitive Surgical, Inc.

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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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.