Precision Endoscopic Infrared Coagulator; Model 5100 Single-Use Disposable Maxi-Guide Flexible Lightguide; Model 5100-2

FDA 510(k) K122593 · Optim, LLC

Substantially Equivalent

510(k) numberK122593

Submission

Device name
Precision Endoscopic Infrared Coagulator; Model 5100 Single-Use Disposable Maxi-Guide Flexible Lightguide; Model 5100-2
Applicant
Optim, LLC
Sturbridge, MA, US
Received
August 24, 2012
Decision date
September 13, 2012
Decision
Substantially Equivalent (SESE)
Type
Special 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
FEH – Electrode, Flexible Suction Coagulator
Device class
Class II (moderate risk)
Regulation
21 CFR 876.4300
Specialty
Gastroenterology, Urology

Other 510(k)s with product code FEH

510(k)DeviceApplicantDecision
K130489Electrode, Flexible Suction CoagulatorFEH · Special Optim, LLC04/19/2013SE
K803214Acmi Bipolar Hemostatic ElectrodeFEH · Traditional American Cystocope Makers, Inc.01/15/1981SE

More from American Cystocope Makers, Inc.

510(k)DeviceDecision
K254133ENTity USB Videoscope SystemEOB · Traditional 05/14/2026SE
K200609ENTity WiFi Video Nasopharyngoscope SystemEOB · Traditional 01/13/2021SE
K130489Electrode, Flexible Suction CoagulatorFEH · Special 04/19/2013SE
K091829PLS Portable Light SourceNTN · Abbreviated 07/28/2009SE
K080622Entity Nasoview LED Nasopharyngoscope, Model 006105EOB · Special 04/02/2008SE

Questions and answers

When was Precision Endoscopic Infrared Coagulator; Model 5100 Single-Use Disposable Maxi-Guide Flexible Lightguide; Model 5100-2 cleared by the FDA?

Precision Endoscopic Infrared Coagulator; Model 5100 Single-Use Disposable Maxi-Guide Flexible Lightguide; Model 5100-2 (K122593) received a 510(k) decision of Substantially Equivalent on September 13, 2012, 20 days after the submission was received.

What is the product code of K122593?

The FDA product code is FEH – Electrode, Flexible Suction Coagulator, a Class II (moderate risk) device regulated under 21 CFR 876.4300.