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FDA 510(k)

E-100 Electrosurgical Generator, SynchroSeal

K-Number: K191280 · 2019-11-14

ApplicantIntuitive Surgical, Inc.
Decision Date2019-11-14
Product CodeNAY
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

E-100 Electrosurgical Generator, SynchroSeal is a medical device manufactured by Intuitive Surgical, Inc.. It received FDA 510(k) clearance on 2019-11-14 under approval number K191280. 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 E-100 Electrosurgical Generator, SynchroSeal?

E-100 Electrosurgical Generator, SynchroSeal is a medical device that received FDA 510(k) clearance on 2019-11-14. It is manufactured by Intuitive Surgical, Inc.. The 510(k) number is K191280.

When was E-100 Electrosurgical Generator, SynchroSeal approved by the FDA?

E-100 Electrosurgical Generator, SynchroSeal received FDA 510(k) clearance on 2019-11-14, under approval number K191280.

What company makes E-100 Electrosurgical Generator, SynchroSeal?

E-100 Electrosurgical Generator, SynchroSeal is manufactured by Intuitive Surgical, Inc..

What is the FDA product code for E-100 Electrosurgical Generator, SynchroSeal?

The FDA product code for E-100 Electrosurgical Generator, SynchroSeal is NAY.

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Related Devices (Code: NAY)

K162411da Vinci Xi 12 – 8 mm ReducerIntuitive Surgical, Inc. K153276da Vinci Xi Surgical SystemIntuitive Surgical, Inc. K161271da Vinci Xi Surgical SystemIntuitive Surgical, Inc. K152892da Vinci Xi Surgical SystemIntuitive Surgical K152578da Vinci Surgical System, Model IS4000Intuitive Surgical, Inc. K152448da Vinci Single-Site Instrument and AccessoriesIntuitive 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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