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FDA 510(k)

da Vinci Single-Site Instrument and Accessories

K-Number: K152448 · 2016-03-09

ApplicantIntuitive Surgical, Inc.
Decision Date2016-03-09
Product CodeNAY
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

da Vinci Single-Site Instrument and Accessories is a medical device manufactured by Intuitive Surgical, Inc.. It received FDA 510(k) clearance on 2016-03-09 under approval number K152448. 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 Single-Site Instrument and Accessories?

da Vinci Single-Site Instrument and Accessories is a medical device that received FDA 510(k) clearance on 2016-03-09. It is manufactured by Intuitive Surgical, Inc.. The 510(k) number is K152448.

When was da Vinci Single-Site Instrument and Accessories approved by the FDA?

da Vinci Single-Site Instrument and Accessories received FDA 510(k) clearance on 2016-03-09, under approval number K152448.

What company makes da Vinci Single-Site Instrument and Accessories?

da Vinci Single-Site Instrument and Accessories is manufactured by Intuitive Surgical, Inc..

What is the FDA product code for da Vinci Single-Site Instrument and Accessories?

The FDA product code for da Vinci Single-Site Instrument and Accessories is NAY.

Related Clinical Trials

NCT06934694 Effect of Instrument-Assisted Soft Tissue Mobilization on Gastrocnemius Stiffness and Ankle Range of Motion COMPLETED NCT07388784 Exploration of the Functional Effect of Modified Gain Precalculation on Soft Speech Intelligibility RECRUITING NCT05672368 The da Vinci Single Port Robotic System for Use in Abdominal and Pelvic Surgical Procedures RECRUITING NCT07522294 Optimization and Standardization of Single-Port Robotic Transanal Minimally Invasive Surgery for Rectal Tumor Excision ACTIVE_NOT_RECRUITING

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 K152421IS4000 Stapler 30 Instrument and Stapler 30 Reloads K151794da Vinci Xi Surgical System

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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. 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.

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