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FDA 510(k)

ELECTRODE, FLEXIBLE SUCTION COAGULATOR

K-Number: K130489 · 2013-04-19

ApplicantOptim, LLC
Decision Date2013-04-19
Product CodeFEH
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

ELECTRODE, FLEXIBLE SUCTION COAGULATOR is the device name listed in this FDA 510(k) record. The listed applicant is Optim, LLC. It received FDA 510(k) clearance on 2013-04-19 under 510(k) number K130489. The device is classified under product code FEH. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ELECTRODE, FLEXIBLE SUCTION COAGULATOR?

ELECTRODE, FLEXIBLE SUCTION COAGULATOR is a medical device that received FDA 510(k) clearance on 2013-04-19. The listed applicant is Optim, LLC. The 510(k) number is K130489.

When did ELECTRODE, FLEXIBLE SUCTION COAGULATOR receive FDA 510(k) clearance?

ELECTRODE, FLEXIBLE SUCTION COAGULATOR received FDA 510(k) clearance on 2013-04-19, under 510(k) number K130489.

Who is the listed applicant for ELECTRODE, FLEXIBLE SUCTION COAGULATOR?

The FDA 510(k) record lists Optim, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ELECTRODE, FLEXIBLE SUCTION COAGULATOR?

The FDA product code for ELECTRODE, FLEXIBLE SUCTION COAGULATOR is FEH.

Related Clinical Trials

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Other records listing Optim, LLC 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.

K254133ENTity USB Videoscope SystemK200609ENTity WiFi Video Nasopharyngoscope SystemK122593PRECISION ENDOSCOPIC INFRARED COAGULATOR; MODEL 5100 SINGLE-USE DISPOSABLE MAXI-GUIDE FLEXIBLE LIGHTGUIDE; MODEL 5100-2

Related Devices (Code: FEH)

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.

K122593PRECISION ENDOSCOPIC INFRARED COAGULATOR; MODEL 5100 SINGLE-USE DISPOSABLE MAXI-GUIDE FLEXIBLE LIGHTGUIDE; MODEL 5100-2Optim, LLCK803214ACMI BIPOLAR HEMOSTATIC ELECTRODEAmerican Cystocope Makers, Inc.

Official Source

View on FDA Database →

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

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