510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K091600Substantially Equivalent

Directvision Guide System

Percuvision, LLC, Gahanna OH / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K091600 is the FDA 510(k) clearance record for DIRECTVISION GUIDE SYSTEM, a class II device, cleared for Percuvision, LLC on under FDA product code FGC (Urethroscope). FDA records list 3 510(k) clearances for Percuvision, LLC, from to . As of , FDA records show no recalls naming K091600.

Clearance record

Decision date
Received
(83 days to decision)
Product code
FGC Urethroscope
Regulation
21 CFR 876.1500
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Percuvision, LLC 765 N. Hamilton Rd., Gahanna OH
510(k) summary
Summary PDF
Third party review
No

Clearances, product code FGC

Trailing 12 months

FDA records hold no clearances under product code FGC in the trailing twelve months.

FDA records show no clearances under product code FGC in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code FGC, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260