Directvision Guide System

FDA 510(k) K091600 · Percuvision, LLC

Substantially Equivalent

510(k) numberK091600

Submission

Device name
Directvision Guide System
Applicant
Percuvision, LLC
Gahanna, OH, US
Received
June 3, 2009
Decision date
August 25, 2009
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
FGC – Urethroscope
Device class
Class II (moderate risk)
Regulation
21 CFR 876.1500
Specialty
Gastroenterology, Urology

Other 510(k)s with product code FGC

510(k)DeviceApplicantDecision
K945907Karl Storz Semi-Rigid Micro-Endoscopes and Accessories for Adult and Pediatric…FGC · Traditional KARL STORZ Endoscopy-America, Inc.05/12/1995SE
K800913Gynecological Cysto/UrethroscopeFGC · Traditional Kli05/14/1980SE

More from Kli

510(k)DeviceDecision
K110214Directvision Catheter, UncoatedEZL · Special 05/27/2011SE
K090262Percucath Urinary CatheterEZL · Traditional 05/28/2009SE

Questions and answers

When was Directvision Guide System cleared by the FDA?

Directvision Guide System (K091600) received a 510(k) decision of Substantially Equivalent on August 25, 2009, 83 days after the submission was received.

What is the product code of K091600?

The FDA product code is FGC – Urethroscope, a Class II (moderate risk) device regulated under 21 CFR 876.1500.