Cleared Special

AMSELF CLOSED CATHETERIZATION SYSTEM

K082831 · Amsino International, Inc. · Gastroenterology & Urology
Oct 2008
Decision
27d
Days
Class 2
Risk

About This 510(k) Submission

K082831 is an FDA 510(k) clearance for the AMSELF CLOSED CATHETERIZATION SYSTEM, a Tray, Catheterization, Sterile Urethral, With Or Without Catheter (kit) (Class II — Special Controls, product code FCM), submitted by Amsino International, Inc. (Pomona, US). The FDA issued a Cleared decision on October 23, 2008, 27 days after receiving the submission on September 26, 2008. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5130.

Submission Details

510(k) Number K082831 FDA.gov
FDA Decision Cleared SESE
Date Received September 26, 2008
Decision Date October 23, 2008
Days to Decision 27 days
Submission Type Special
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF

Device Classification

Product Code FCM — Tray, Catheterization, Sterile Urethral, With Or Without Catheter (kit)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 876.5130

Similar Devices — FCM Tray, Catheterization, Sterile Urethral, With Or Without Catheter (kit)

All 58
Cure Catheter Insertion Kit (K1); Cure Catheter Insertion Kit (K2); Cure Catheter Insertion Kit (K2-90); Cure Catheter Insertion Kit (K3); Cure Hydrophilic Catheter Kit (HM12UK); Cure Hydrophilic Catheter Kit (HM14UK); Cure Hydrophilic Catheter Kit (HM16UK); Cure Pocket Catheter Kit (M14UK); Cure Catheter Closed System Kit (CS8); Cure Catheter Closed System Kit (CS10); Cure Catheter Closed System Kit (CS12); Cure Catheter Closed System Kit (CS14); Cure Catheter Closed System Kit (CS14C
K250891 · Convatec Limited · Jun 2025
Self-Cath Closed System
K223821 · Coloplast · Aug 2023
SELF-CATH CS CLOSED URINARY CATHETERIZATION SYSTEM
K070939 · Coloplast Manufacturing Us, LLC · Jun 2007
GUARDIAN CATHETER-INFANT URINARY COLLECTION KIT
K070048 · Marian Medical, Inc. · Mar 2007
AMSURE FOLEY INSERTION TRAY
K030664 · Amsino International, Inc. · May 2003
AMSURE URETHRAL CATHETERIZATION TRAY
K030712 · Amsino International, Inc. · May 2003