510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K191341Substantially Equivalent

Veloxion Controller Kit, Veloxion Fluid Control Set, Veloxion Resectoscope, Veloxion Video Control Unit, Veloxion Roll Stand, Waste Management Tubing, Tissue Catch, Waste Management Bags

Corinth Medtech, Inc., Cupertino CA / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K191341 is the FDA 510(k) clearance record for Veloxion Controller Kit, Veloxion Fluid Control Set, Veloxion Resectoscope, Veloxion Video Control Unit, Veloxion Roll Stand, Waste Management Tubing, Tissue Catch, Waste Management Bags, a class II device, cleared for Corinth Medtech, Inc. on under FDA product code FJL (Resectoscope). FDA records list 7 510(k) clearances for Corinth Medtech, Inc., from to . As of , FDA records show no recalls naming K191341.

Clearance record

Decision date
Received
(24 days to decision)
Product code
FJL Resectoscope
Regulation
21 CFR 876.1500
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Corinth Medtech, Inc. 1601 S. De Anza Blvd., Suite 200, Cupertino CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code FJL

Trailing 12 months

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

FDA records show no clearances under product code FJL in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code FJL, 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