510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K851684Substantially Equivalent

Urotec/franklin Soft Simplastic Catheter

Urotec Systems Corp., Pittsburgh PA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K851684 is the FDA 510(k) clearance record for UROTEC/FRANKLIN SOFT SIMPLASTIC CATHETER, a class II device, cleared for Urotec Systems Corp. on under FDA product code KOD (Catheter, Urological). FDA records list 2 510(k) clearances for Urotec Systems Corp., from to . As of , FDA records show no recalls naming K851684.

Clearance record

Decision date
Received
(70 days to decision)
Product code
KOD Catheter, Urological
Regulation
21 CFR 876.5130
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Urotec Systems Corp. 1000 California Ave., Pittsburgh PA
Third party review
No

Clearances, product code KOD

Trailing 12 months
1 clearance under product code KOD in the twelve months to October 2026, February 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code KOD, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20261
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260