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FDA 510(k)

da Vinci E-200 Electrosurgical Generator

K-Number: K223039 · 2022-11-28

ApplicantIntuitive Surgical
Decision Date2022-11-28
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

da Vinci E-200 Electrosurgical Generator is the device name listed in this FDA 510(k) record. The listed applicant is Intuitive Surgical. It received FDA 510(k) clearance on 2022-11-28 under 510(k) number K223039. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the da Vinci E-200 Electrosurgical Generator?

da Vinci E-200 Electrosurgical Generator is a medical device that received FDA 510(k) clearance on 2022-11-28. The listed applicant is Intuitive Surgical. The 510(k) number is K223039.

When did da Vinci E-200 Electrosurgical Generator receive FDA 510(k) clearance?

da Vinci E-200 Electrosurgical Generator received FDA 510(k) clearance on 2022-11-28, under 510(k) number K223039.

Who is the listed applicant for da Vinci E-200 Electrosurgical Generator?

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

What is the FDA product code for da Vinci E-200 Electrosurgical Generator?

The FDA product code for da Vinci E-200 Electrosurgical Generator is GEI.

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.

NCT04403022da Vinci SP® Investigational Device Exemption Study in Colorectal ProceduresACTIVE_NOT_RECRUITINGNCT05867927GENERATE - Next GENERATion of GynEcological Surgery - Robotic Assisted Surgery in Gynecological IndicationsRECRUITINGNCT06084208Assessment of Diagnostic Yield Using a Robotic Navigational Bronchoscopy System With CBCTCOMPLETEDNCT06308120A Trial to Compare Robotic Assisted Bronchoscopy Ion's Clinical Utility for Peripheral Lung Nodule Access and Diagnosis to ENBACTIVE_NOT_RECRUITINGNCT06923774European Real-World Registry for Use of the Ion Endoluminal SystemRECRUITINGNCT07655505Use of Force Feedback Instruments With the da Vinci Surgical System, Model IS5000 for Mitral Valve RepairRECRUITING

Other records listing Intuitive Surgical 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.

K253702Intuitive Endoluminal Gastrointestinal System (IG1000)K261824da Vinci Surgical System, Model IS5000K261249Universal Seal (5-12 mm)K260695da Vinci Firefly Imaging SystemK253986da Vinci Force Feedback InstrumentsK253978Universal Seal (5-12 mm)

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Related Devices (Code: GEI)

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.

K261179AlphaTriPart - Monopolar MIC InstrumentsGimmi GmbHK253504Volnewmer™Classys, Inc.K254056THUNDERBEAT 5 mm, 45 cm, Front-actuated Grip Type S (TB-0545FCS); THUNDERBEAT 5 mm, 35 cm, Front-actuated Grip Type S (TB-0535FCS); THUNDERBEAT 5 mm, 20 cm, Front-actuated Grip Type S (TB-0520FCS)Olympus Medical Systems Corp.K253484LUTRONIC GENIUSCynosure Lutronic Technology CorporationK251492Irrigation Tubing Bipolar Cord SetNew Deantronics Taiwan , Ltd.K260636Remanufactured LigaSure XP Maryland Jaw Sealer/Divider Without Nano-coatingStryker Sustainability Solutions

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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