Spyglass Irrigation System

FDA 510(k) K063700 · Medical Scientific, Inc.

Substantially Equivalent

510(k) numberK063700

Submission

Device name
Spyglass Irrigation System
Applicant
Medical Scientific, Inc.
Taunton, MA, US
Received
December 13, 2006
Decision date
February 8, 2007
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
LJH – System, Irrigation, Urological
Device class
Class II (moderate risk)
Regulation
21 CFR 876.5130
Specialty
Gastroenterology, Urology

Other 510(k)s with product code LJH

510(k)DeviceApplicantDecision
K254111Irrigation/Urology SetsLJH · Traditional B.Braun Medical, Inc.09/10/2026SE
K162992Karl Storz UROMAT E.A.S.I.LJH · Traditional Karl Storz Endoscopy America, Inc.07/07/2017SE
K070873Amsure Bladder Irrigation SetLJH · Traditional Amsino Intl., Inc.12/19/2007SE
K071832Modifcation to: Spyglass Irrigation SystemLJH · Special Medical Scientific, Inc.09/18/2007SE
K062551Nexus Irrigation Tubing SetLJH · Traditional Nexus Medical, LLC12/15/2006SE
K042457Uro ProLJH · Traditional W.O.M. World of Medicine AG10/25/2004SE
K040094Piggyback Irrigating SystemLJH · Abbreviated Kosin Technologies, LLC04/15/2004SE
K023808Irrigation SetsLJH · Traditional International Medsurg Connection03/10/2003SE
K010607Med-Rx Irrigation Set, Model 10-3001, 10-3002, 10-4000, 10-4001LJH · Traditional Benlan, Inc.11/28/2001SE
K010122Continuous Flow Y-TubingLJH · Traditional G.U.-Tek06/04/2001SE

More from G.U.-Tek

510(k)DeviceDecision
K071832Modifcation to: Spyglass Irrigation SystemLJH · Special 09/18/2007SE
K031564CSSGEI · Special 10/07/2003SE
K011202Msi Bipolar SheathHRX · Traditional 12/31/2001SE
K981387Evanesce Scar Management SystemMDA · Traditional 06/10/1998SE

Questions and answers

When was Spyglass Irrigation System cleared by the FDA?

Spyglass Irrigation System (K063700) received a 510(k) decision of Substantially Equivalent on February 8, 2007, 57 days after the submission was received.

What is the product code of K063700?

The FDA product code is LJH – System, Irrigation, Urological, a Class II (moderate risk) device regulated under 21 CFR 876.5130.