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FDA 510(k)

Sutter Arrowtip Monopolar Electrodes

K-Number: K192128 · 2019-10-04

ApplicantSutter Medizintechnik GmbH
Decision Date2019-10-04
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Sutter Arrowtip Monopolar Electrodes is the device name listed in this FDA 510(k) record. The listed applicant is Sutter Medizintechnik GmbH. It received FDA 510(k) clearance on 2019-10-04 under 510(k) number K192128. 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 Sutter Arrowtip Monopolar Electrodes?

Sutter Arrowtip Monopolar Electrodes is a medical device that received FDA 510(k) clearance on 2019-10-04. The listed applicant is Sutter Medizintechnik GmbH. The 510(k) number is K192128.

When did Sutter Arrowtip Monopolar Electrodes receive FDA 510(k) clearance?

Sutter Arrowtip Monopolar Electrodes received FDA 510(k) clearance on 2019-10-04, under 510(k) number K192128.

Who is the listed applicant for Sutter Arrowtip Monopolar Electrodes?

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

What is the FDA product code for Sutter Arrowtip Monopolar Electrodes?

The FDA product code for Sutter Arrowtip Monopolar Electrodes is GEI.

Other records listing Sutter Medizintechnik GmbH 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.

K251813CURIS II RF Generator (REF 360100-05)K233425FlexTip Bipolar electrodes single-use (AR-S9805-0028), FlexTip Bipolar electrodes single-use (AR-S9805-0035)K193587Sutter Swyng non-stick bipolar forceps, single-useK191732Sutter RaVoR Bipolar ElectrodesK171869Sutter CURIS RF Generator

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

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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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