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FDA 510(k)

INTUITIVE SURGICAL ONSITE FOR DA VINCI SURGICAL SYSTEMS

K-Number: K121921 · 2012-10-25

ApplicantIntuitive Surgical, Inc.
Decision Date2012-10-25
Product CodeNAY
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

INTUITIVE SURGICAL ONSITE FOR DA VINCI SURGICAL SYSTEMS is the device name listed in this FDA 510(k) record. The listed applicant is Intuitive Surgical, Inc.. It received FDA 510(k) clearance on 2012-10-25 under 510(k) number K121921. 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 INTUITIVE SURGICAL ONSITE FOR DA VINCI SURGICAL SYSTEMS?

INTUITIVE SURGICAL ONSITE FOR DA VINCI SURGICAL SYSTEMS is a medical device that received FDA 510(k) clearance on 2012-10-25. The listed applicant is Intuitive Surgical, Inc.. The 510(k) number is K121921.

When did INTUITIVE SURGICAL ONSITE FOR DA VINCI SURGICAL SYSTEMS receive FDA 510(k) clearance?

INTUITIVE SURGICAL ONSITE FOR DA VINCI SURGICAL SYSTEMS received FDA 510(k) clearance on 2012-10-25, under 510(k) number K121921.

Who is the listed applicant for INTUITIVE SURGICAL ONSITE FOR DA VINCI SURGICAL SYSTEMS?

The FDA 510(k) record lists Intuitive Surgical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for INTUITIVE SURGICAL ONSITE FOR DA VINCI SURGICAL SYSTEMS?

The FDA product code for INTUITIVE SURGICAL ONSITE FOR DA VINCI SURGICAL SYSTEMS is NAY.

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Other records listing Intuitive Surgical, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261823da Vinci Surgical System, Model IS5000K253702Intuitive Endoluminal Gastrointestinal System (IG1000)K261824da Vinci Surgical System, Model IS5000K261249Universal Seal (5-12 mm)K253986da Vinci Force Feedback InstrumentsK253978Universal Seal (5-12 mm)

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Related Devices (Code: NAY)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261823da Vinci Surgical System, Model IS5000Intuitive Surgical, Inc.K261824da Vinci Surgical System, Model IS5000Intuitive Surgical, Inc.K260695da Vinci Firefly Imaging SystemIntuitive SurgicalK254192Senhance Ultrasonic SystemAsensus SurgicalK253986da Vinci Force Feedback InstrumentsIntuitive Surgical, Inc.K251739da Vinci Surgical System (IS5000)Intuitive 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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