da Vinci Xi 12 8 mm Reducer
K-Number: K162411 · 2016-09-21
ApplicantIntuitive Surgical, Inc.
Decision Date2016-09-21
Product CodeNAY
Advisory CommitteeGU
DecisionSubstantially Equivalent
Device Summary
da Vinci Xi 12 8 mm Reducer is a medical device manufactured by Intuitive Surgical, Inc.. It received FDA 510(k) clearance on 2016-09-21 under approval number K162411. 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 Xi 12 8 mm Reducer?
da Vinci Xi 12 8 mm Reducer is a medical device that received FDA 510(k) clearance on 2016-09-21. It is manufactured by Intuitive Surgical, Inc.. The 510(k) number is K162411.
When was da Vinci Xi 12 8 mm Reducer approved by the FDA?
da Vinci Xi 12 8 mm Reducer received FDA 510(k) clearance on 2016-09-21, under approval number K162411.
What company makes da Vinci Xi 12 8 mm Reducer?
da Vinci Xi 12 8 mm Reducer is manufactured by Intuitive Surgical, Inc..
What is the FDA product code for da Vinci Xi 12 8 mm Reducer?
The FDA product code for da Vinci Xi 12 8 mm Reducer is NAY.
Other Devices by Intuitive Surgical, Inc.
Related Devices (Code: NAY)
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.
K152421IS4000 Stapler 30 Instrument and Stapler 30 ReloadsIntuitive 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.