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FDA 510(k)

PRECISION ENDOSCOPIC INFRARED COAGULATOR; MODEL 5100 SINGLE-USE DISPOSABLE MAXI-GUIDE FLEXIBLE LIGHTGUIDE; MODEL 5100-2

K-Number: K122593 · 2012-09-13

ApplicantOptim, LLC
Decision Date2012-09-13
Product CodeFEH
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

PRECISION ENDOSCOPIC INFRARED COAGULATOR; MODEL 5100 SINGLE-USE DISPOSABLE MAXI-GUIDE FLEXIBLE LIGHTGUIDE; MODEL 5100-2 is the device name listed in this FDA 510(k) record. The listed applicant is Optim, LLC. It received FDA 510(k) clearance on 2012-09-13 under 510(k) number K122593. 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 PRECISION ENDOSCOPIC INFRARED COAGULATOR; MODEL 5100 SINGLE-USE DISPOSABLE MAXI-GUIDE FLEXIBLE LIGHTGUIDE; MODEL 5100-2?

PRECISION ENDOSCOPIC INFRARED COAGULATOR; MODEL 5100 SINGLE-USE DISPOSABLE MAXI-GUIDE FLEXIBLE LIGHTGUIDE; MODEL 5100-2 is a medical device that received FDA 510(k) clearance on 2012-09-13. The listed applicant is Optim, LLC. The 510(k) number is K122593.

When did PRECISION ENDOSCOPIC INFRARED COAGULATOR; MODEL 5100 SINGLE-USE DISPOSABLE MAXI-GUIDE FLEXIBLE LIGHTGUIDE; MODEL 5100-2 receive FDA 510(k) clearance?

PRECISION ENDOSCOPIC INFRARED COAGULATOR; MODEL 5100 SINGLE-USE DISPOSABLE MAXI-GUIDE FLEXIBLE LIGHTGUIDE; MODEL 5100-2 received FDA 510(k) clearance on 2012-09-13, under 510(k) number K122593.

Who is the listed applicant for PRECISION ENDOSCOPIC INFRARED COAGULATOR; MODEL 5100 SINGLE-USE DISPOSABLE MAXI-GUIDE FLEXIBLE LIGHTGUIDE; MODEL 5100-2?

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 PRECISION ENDOSCOPIC INFRARED COAGULATOR; MODEL 5100 SINGLE-USE DISPOSABLE MAXI-GUIDE FLEXIBLE LIGHTGUIDE; MODEL 5100-2?

The FDA product code for PRECISION ENDOSCOPIC INFRARED COAGULATOR; MODEL 5100 SINGLE-USE DISPOSABLE MAXI-GUIDE FLEXIBLE LIGHTGUIDE; MODEL 5100-2 is FEH.

Related Clinical Trials

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.

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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 SystemK130489ELECTRODE, FLEXIBLE SUCTION COAGULATOR

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.

K130489ELECTRODE, FLEXIBLE SUCTION COAGULATOROptim, 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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