510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K223821Substantially Equivalent

Self-Cath Closed System

MEDLINE INDUSTRIES, LP - Northfield, Plymouth MN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K223821 is the FDA 510(k) clearance record for Self-Cath Closed System, a class II device, cleared for Coloplast on under FDA product code FCM (Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit)). FDA records list 414 510(k) clearances for MEDLINE INDUSTRIES, LP - Northfield, from to . As of , FDA records show no recalls naming K223821.

Clearance record

Decision date
Received
(224 days to decision)
Product code
FCM Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit)
Regulation
21 CFR 876.5130
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Coloplast 1601 W. River Rd. N., Plymouth MN
510(k) summary
Summary PDF
Third party review
No

Clearances, product code FCM

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