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FDA 510(k)

Sutter Swyng non-stick bipolar forceps, single-use

K-Number: K193587 · 2020-02-10

ApplicantSutter Medizintechnik GmbH
Decision Date2020-02-10
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Sutter Swyng non-stick bipolar forceps, single-use 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 2020-02-10 under 510(k) number K193587. 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 Swyng non-stick bipolar forceps, single-use?

Sutter Swyng non-stick bipolar forceps, single-use is a medical device that received FDA 510(k) clearance on 2020-02-10. The listed applicant is Sutter Medizintechnik GmbH. The 510(k) number is K193587.

When did Sutter Swyng non-stick bipolar forceps, single-use receive FDA 510(k) clearance?

Sutter Swyng non-stick bipolar forceps, single-use received FDA 510(k) clearance on 2020-02-10, under 510(k) number K193587.

Who is the listed applicant for Sutter Swyng non-stick bipolar forceps, single-use?

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 Swyng non-stick bipolar forceps, single-use?

The FDA product code for Sutter Swyng non-stick bipolar forceps, single-use 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)K192128Sutter 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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