510(k) K223821

Device: Self-Cath Closed System
Applicant: Coloplast
510(k) number: K223821
Product code: FCM
Decision: Substantially Equivalent (SESE)
Decision date: 2023-08-02
Date received: 2022-12-21
Regulation: 876.5130
Classification name: Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit)
Medical specialty: Gastroenterology, Urology
Review panel: Gastroenterology, Urology
Device class: 2
Clearance type: Traditional
Statement or summary: Summary
Third party reviewed: No

Related Records

Applicant Contact

Contact: Preeti Jain
Address: 1601 W. River Rd. N. Plymouth MN US 55411 55411

FDA Registration Numbers

3015173212
3014404707
1423537
3005669815
3011987967
3012445205
3017937889
3013188547
3014656749
3010220595
2648727
1043214
2320762
3011707784
2029015
1921846
3022518300
9611590
1055236
3006430057
9680787
3002993863
3004111573
3015142802
3018116884
1420054
3004727093
3008191244
1650927
3008806809
3014421917
9610849
3006673317
3015176887
2032112
9610694
2011171
8040607
2320961
1647149
3006082230
3017961114
3011137372
1018233
1054241
1480288
3005012805
9612030
3006542380
8040412
1928237
3007185216
3030087693
3009609358
3004122598
3004365956

Source Documents

510(k) summary PDF

Other 510(k) Records For Product Code FCM

510(k)	Device	Applicant	Decision date
K250891	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	Convatec Limited	2025-06-06
K082831	AMSELF CLOSED CATHETERIZATION SYSTEM	Amsino International, Inc.	2008-10-23
K070939	SELF-CATH CS CLOSED URINARY CATHETERIZATION SYSTEM	Coloplast Manufacturing Us, LLC	2007-06-01
K070048	GUARDIAN CATHETER-INFANT URINARY COLLECTION KIT	Marian Medical, Inc.	2007-03-15
K030664	AMSURE FOLEY INSERTION TRAY	Amsino International, Inc.	2003-05-23
K030712	AMSURE URETHRAL CATHETERIZATION TRAY	Amsino International, Inc.	2003-05-23
K011055	THE O'NEIL STERILE FIELD URINARY CATHETER KIT WITH PREP PADS	Go Medical Industries Pty. , Ltd.	2001-06-06
K010420	RUSCH MMG/O'NEIL CATHETER	Rusch, Inc.	2001-05-09
K003873	MENTOR SELF-CATH CLOSED SYSTEM	Mentor Corp.	2001-03-29
K002803	THE O'NEIL STERILE FIELD URINARY CATHETER KIT	Go Medical Industries Pty. , Ltd.	2000-12-27
K983010	SELF CATH SET/SAFETY CATH	Rusch Intl.	1999-02-12
K963993	RUSCH SIMPLASTIC FOLEY CATHETERIZATION SET	Rusch, Inc.	1996-12-17
K962254	NHMC URETHRAL CATHETERIZATION TRAY	National Healthcare Mfg. Corp.	1996-07-29
K962073	URETHRAL CATHETERIZATION TRAY/UNIVERSAL URETHRAL CATH TRAY	Continental Medical Laboratories, Inc.	1996-06-21
K961442	UNIVERSAL DRAINAGE TRAY	Customed, Inc.	1996-05-09