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FDA 510(k)

DA VINCI FLUORESCENCE IMAGING VISION SYSTEM, MODEL FF 100

K-Number: K101077 · 2011-02-04

ApplicantIntuitive Surgical, Inc.
Decision Date2011-02-04
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

DA VINCI FLUORESCENCE IMAGING VISION SYSTEM, MODEL FF 100 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 2011-02-04 under 510(k) number K101077. The device is classified under product code GCJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DA VINCI FLUORESCENCE IMAGING VISION SYSTEM, MODEL FF 100?

DA VINCI FLUORESCENCE IMAGING VISION SYSTEM, MODEL FF 100 is a medical device that received FDA 510(k) clearance on 2011-02-04. The listed applicant is Intuitive Surgical, Inc.. The 510(k) number is K101077.

When did DA VINCI FLUORESCENCE IMAGING VISION SYSTEM, MODEL FF 100 receive FDA 510(k) clearance?

DA VINCI FLUORESCENCE IMAGING VISION SYSTEM, MODEL FF 100 received FDA 510(k) clearance on 2011-02-04, under 510(k) number K101077.

Who is the listed applicant for DA VINCI FLUORESCENCE IMAGING VISION SYSTEM, MODEL FF 100?

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 DA VINCI FLUORESCENCE IMAGING VISION SYSTEM, MODEL FF 100?

The FDA product code for DA VINCI FLUORESCENCE IMAGING VISION SYSTEM, MODEL FF 100 is GCJ.

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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: GCJ)

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.

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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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