Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

INTUITIVE SURGICAL DA VINCI SURGICAL SYSTEM, MODEL ISI 1000

K-Number: K011002 · 2001-05-30

ApplicantIntuitive Surgical, Inc.
Decision Date2001-05-30
Product CodeNAY
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

INTUITIVE SURGICAL DA VINCI SURGICAL SYSTEM, MODEL ISI 1000 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 2001-05-30 under 510(k) number K011002. 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 DA VINCI SURGICAL SYSTEM, MODEL ISI 1000?

INTUITIVE SURGICAL DA VINCI SURGICAL SYSTEM, MODEL ISI 1000 is a medical device that received FDA 510(k) clearance on 2001-05-30. The listed applicant is Intuitive Surgical, Inc.. The 510(k) number is K011002.

When did INTUITIVE SURGICAL DA VINCI SURGICAL SYSTEM, MODEL ISI 1000 receive FDA 510(k) clearance?

INTUITIVE SURGICAL DA VINCI SURGICAL SYSTEM, MODEL ISI 1000 received FDA 510(k) clearance on 2001-05-30, under 510(k) number K011002.

Who is the listed applicant for INTUITIVE SURGICAL DA VINCI SURGICAL SYSTEM, MODEL ISI 1000?

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 DA VINCI SURGICAL SYSTEM, MODEL ISI 1000?

The FDA product code for INTUITIVE SURGICAL DA VINCI SURGICAL SYSTEM, MODEL ISI 1000 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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

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)

View all 164 devices →

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.K253556da Vinci SP Surgical System (SP1098); da Vinci E-200 GeneratorIntuitive 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.

↑