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FDA 510(k)

FlexTip Bipolar electrodes single-use (AR-S9805-0028), FlexTip Bipolar electrodes single-use (AR-S9805-0035)

K-Number: K233425 · 2024-01-25

ApplicantSutter Medizintechnik GmbH
Decision Date2024-01-25
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

FlexTip Bipolar electrodes single-use (AR-S9805-0028), FlexTip Bipolar electrodes single-use (AR-S9805-0035) 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 2024-01-25 under 510(k) number K233425. 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 FlexTip Bipolar electrodes single-use (AR-S9805-0028), FlexTip Bipolar electrodes single-use (AR-S9805-0035)?

FlexTip Bipolar electrodes single-use (AR-S9805-0028), FlexTip Bipolar electrodes single-use (AR-S9805-0035) is a medical device that received FDA 510(k) clearance on 2024-01-25. The listed applicant is Sutter Medizintechnik GmbH. The 510(k) number is K233425.

When did FlexTip Bipolar electrodes single-use (AR-S9805-0028), FlexTip Bipolar electrodes single-use (AR-S9805-0035) receive FDA 510(k) clearance?

FlexTip Bipolar electrodes single-use (AR-S9805-0028), FlexTip Bipolar electrodes single-use (AR-S9805-0035) received FDA 510(k) clearance on 2024-01-25, under 510(k) number K233425.

Who is the listed applicant for FlexTip Bipolar electrodes single-use (AR-S9805-0028), FlexTip Bipolar electrodes single-use (AR-S9805-0035)?

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 FlexTip Bipolar electrodes single-use (AR-S9805-0028), FlexTip Bipolar electrodes single-use (AR-S9805-0035)?

The FDA product code for FlexTip Bipolar electrodes single-use (AR-S9805-0028), FlexTip Bipolar electrodes single-use (AR-S9805-0035) 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)K193587Sutter Swyng non-stick bipolar forceps, single-useK192128Sutter Arrowtip Monopolar ElectrodesK191732Sutter 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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