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FDA 510(k)

Minimally Invasive Sealer (MIS) Flex, Minimally Invasive Sealer (MIS) Flex Mini

K-Number: K170381 · 2017-09-07

ApplicantMedtronic Advanced Energy
Decision Date2017-09-07
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Minimally Invasive Sealer (MIS) Flex, Minimally Invasive Sealer (MIS) Flex Mini is a medical device manufactured by Medtronic Advanced Energy. It received FDA 510(k) clearance on 2017-09-07 under approval number K170381. 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 Minimally Invasive Sealer (MIS) Flex, Minimally Invasive Sealer (MIS) Flex Mini?

Minimally Invasive Sealer (MIS) Flex, Minimally Invasive Sealer (MIS) Flex Mini is a medical device that received FDA 510(k) clearance on 2017-09-07. It is manufactured by Medtronic Advanced Energy. The 510(k) number is K170381.

When was Minimally Invasive Sealer (MIS) Flex, Minimally Invasive Sealer (MIS) Flex Mini approved by the FDA?

Minimally Invasive Sealer (MIS) Flex, Minimally Invasive Sealer (MIS) Flex Mini received FDA 510(k) clearance on 2017-09-07, under approval number K170381.

What company makes Minimally Invasive Sealer (MIS) Flex, Minimally Invasive Sealer (MIS) Flex Mini?

Minimally Invasive Sealer (MIS) Flex, Minimally Invasive Sealer (MIS) Flex Mini is manufactured by Medtronic Advanced Energy.

What is the FDA product code for Minimally Invasive Sealer (MIS) Flex, Minimally Invasive Sealer (MIS) Flex Mini?

The FDA product code for Minimally Invasive Sealer (MIS) Flex, Minimally Invasive Sealer (MIS) Flex Mini is GEI.

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Related PubMed Literature

PMID: 41886403 Urologic Device Innovation and Trends: An Analysis of Food and Drug Administration Approvals From 1990 to 2023. Urology practice (2026) PMID: 41518328 Surface Energy and Pinning Forces of Fluorine-Free, Water-Friendly Coatings for Medical Devices. Langmuir : the ACS journal of surfaces and colloids (2026) PMID: 40856794 [Translational challenges and clinical potential of artificial intelligence in minimally invasive surgery]. Chirurgie (Heidelberg, Germany) (2025) PMID: 40054052 Development of medical devices driven by academia-industry collaboration: An internal audit. Surgery (2025)

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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