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FDA 510(k)

5 MM HARMONIC ACE INSTRUMENT (USED WITH DA VINCI IS1200 & IS2000/IS3000 SYSTEM)

K-Number: K093217 · 2010-01-21

ApplicantIntuitive Surgical, Inc.
Decision Date2010-01-21
Product CodeNAY
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

5 MM HARMONIC ACE INSTRUMENT (USED WITH DA VINCI IS1200 & IS2000/IS3000 SYSTEM) 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 2010-01-21 under 510(k) number K093217. 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 5 MM HARMONIC ACE INSTRUMENT (USED WITH DA VINCI IS1200 & IS2000/IS3000 SYSTEM)?

5 MM HARMONIC ACE INSTRUMENT (USED WITH DA VINCI IS1200 & IS2000/IS3000 SYSTEM) is a medical device that received FDA 510(k) clearance on 2010-01-21. The listed applicant is Intuitive Surgical, Inc.. The 510(k) number is K093217.

When did 5 MM HARMONIC ACE INSTRUMENT (USED WITH DA VINCI IS1200 & IS2000/IS3000 SYSTEM) receive FDA 510(k) clearance?

5 MM HARMONIC ACE INSTRUMENT (USED WITH DA VINCI IS1200 & IS2000/IS3000 SYSTEM) received FDA 510(k) clearance on 2010-01-21, under 510(k) number K093217.

Who is the listed applicant for 5 MM HARMONIC ACE INSTRUMENT (USED WITH DA VINCI IS1200 & IS2000/IS3000 SYSTEM)?

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 5 MM HARMONIC ACE INSTRUMENT (USED WITH DA VINCI IS1200 & IS2000/IS3000 SYSTEM)?

The FDA product code for 5 MM HARMONIC ACE INSTRUMENT (USED WITH DA VINCI IS1200 & IS2000/IS3000 SYSTEM) is NAY.

Related Clinical Trials

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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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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