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FDA 510(k)

CURIS II RF Generator (REF 360100-05)

K-Number: K251813 · 2026-02-11

ApplicantSutter Medizintechnik GmbH
Decision Date2026-02-11
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

CURIS II RF Generator (REF 360100-05) 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 2026-02-11 under 510(k) number K251813. 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 CURIS II RF Generator (REF 360100-05)?

CURIS II RF Generator (REF 360100-05) is a medical device that received FDA 510(k) clearance on 2026-02-11. The listed applicant is Sutter Medizintechnik GmbH. The 510(k) number is K251813.

When did CURIS II RF Generator (REF 360100-05) receive FDA 510(k) clearance?

CURIS II RF Generator (REF 360100-05) received FDA 510(k) clearance on 2026-02-11, under 510(k) number K251813.

Who is the listed applicant for CURIS II RF Generator (REF 360100-05)?

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 CURIS II RF Generator (REF 360100-05)?

The FDA product code for CURIS II RF Generator (REF 360100-05) 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.

K233425FlexTip Bipolar electrodes single-use (AR-S9805-0028), FlexTip Bipolar electrodes single-use (AR-S9805-0035)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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