510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K071496Unknown

Icath, Sterilesure

Colorado Catheter Company, Inc., Colorado Springs CO / Traditional, Unknown
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K071496 is the FDA 510(k) clearance record for ICATH, STERILESURE, a class II device, cleared for Colorado Catheter Company, Inc. on under FDA product code NWO (Kit, Catheter, Urinary (Exludes Hiv Testing)). FDA's definition for product code NWO reads: "Urinary Catheterization Kit (Excludes HIV Testing)". FDA records list one 510(k) clearance for Colorado Catheter Company, Inc. As of , FDA records show no recalls naming K071496.

Clearance record

Decision date
Received
(76 days to decision)
Product code
NWO Kit, Catheter, Urinary (Exludes Hiv Testing)
Regulation
21 CFR 876.5130
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Colorado Catheter Company, Inc. 15975 Winding Trl. Rd., Colorado Springs CO
510(k) summary
Summary PDF
Third party review
Yes

Clearances, product code NWO

Trailing 12 months

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

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