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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 the device name listed in this FDA 510(k) record. The listed applicant is Intuitive Surgical, Inc.. It received FDA 510(k) clearance on 2019-11-14 under 510(k) 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. The listed applicant is Intuitive Surgical, Inc.. The 510(k) number is K191280.

When did E-100 Electrosurgical Generator, SynchroSeal receive FDA 510(k) clearance?

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

Who is the listed applicant for E-100 Electrosurgical Generator, SynchroSeal?

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 E-100 Electrosurgical Generator, SynchroSeal?

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

Related Clinical Trials

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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.

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)

View all 124 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.

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.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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