510(k) K122593

Device: PRECISION ENDOSCOPIC INFRARED COAGULATOR; MODEL 5100 SINGLE-USE DISPOSABLE MAXI-GUIDE FLEXIBLE LIGHTGUIDE; MODEL 5100-2
Applicant: OPTIM LLC
510(k) number: K122593
Product code: FEH
Decision: Substantially Equivalent (SESE)
Decision date: 2012-09-13
Date received: 2012-08-24
Regulation: 876.4300
Classification name: Electrode, Flexible Suction Coagulator
Medical specialty: Gastroenterology/Urology
Review panel: Gastroenterology/Urology
Device class: 2
Clearance type: Special
Statement or summary: Summary
Third party reviewed: No

Applicant Contact#

Contact: JEFF BARRETT
Address: 64 Technology Park Rd. Sturbridge MA US 01566 01566

FDA Registration Numbers#

3004491689
1320894
1721686

Source Documents#

Other 510(k) Records For Product Code FEH #

510(k), Device, Applicant table
510(k)	Device	Applicant	Decision date
K130489	ELECTRODE, FLEXIBLE SUCTION COAGULATOR	Optim, LLC	2013-04-19
K803214	ACMI BIPOLAR HEMOSTATIC ELECTRODE	American Cystocope Makers, Inc.	1981-01-15

Legacy Summary#

summary

FDA Review#

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