Product Code: EZD FDA class 2 21 CFR 876.5130

Catheter, Straight

Gastroenterology, Urology

The Straight Catheter (product code EZD) is a basic urinary catheter with a straight tip used to drain urine from the bladder or to instill fluids. It is an FDA Class 2 device (moderate risk), requiring 510(k) clearance before marketing. It is regulated under 21 CFR 876.5130 in the Gastroenterology and Urology specialty. This device is eligible for third-party 510(k) review.

View on FDA

510(k)s

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

Research product code EZD in seconds

The Research Assistant summarizes clearances, adverse event trends and regulation context for a product code — and cites every record.

Free to try · every answer cites its records

Ask the Research Assistant See examples

Basic Information

Product Code: EZD
Device Class: FDA class 2
Regulation Number: 876.5130
Medical Specialty: Gastroenterology, Urology
Review Panel: GU
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✓

Third Party

—

Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 82 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K253295	Coude Sleeved IC; Coude Plus Sleeved IC	May 18, 2026	Substantially Equivalent	Hollister Incorporated
K260999	LoFric Elle Pro	Apr 24, 2026	Substantially Equivalent	Wellspect AB
K252943	GentleCath Air for Men; GentleCath Glide Intermittent Catheter; GentleCath Air for Women	Apr 01, 2026	Substantially Equivalent	Convatec Limited
K260502	Liv Pre-lubricated Intermittent Catheter	Mar 12, 2026	Substantially Equivalent	HR Healthcare
K251274	EZ-Protect Hydrophilic Closed System Intermittent Catheter; EZ-Protect Hydrophilic Closed System Intermittent Catheter Kits	Jan 29, 2026	Unknown	HR Healthcare
K251178	Ready to use Nelaton Catheter	Jan 02, 2026	Substantially Equivalent	Jamjoom Fullcare Corporation
K251468	Sleeved IC 3 Family Sleeved IC 3 SWT (name not finalized) Sleeved IC 3 Pocket (name not finalized) Sleeved IC 3 Plus (name not finalized) Sleeved IC 3 Plus Pocket (name not finalized) (N/A)	Oct 03, 2025	Substantially Equivalent	Hollister Incorporated
K250659	LoFric Origo	Sep 26, 2025	Substantially Equivalent	Wellspect AB
K250699	Cure Twist Female 8 Catheter (T8); Cure Twist Female 10 Catheter (T10); Cure Twist Female 12 Catheter (T12); Cure Twist Female 14 Catheter (T14); Cure Twist Female 16 Catheter (T16); Cure Twist Female 8 Catheter Kit with supplies (T8K); Cure Twist Female 10 Catheter Kit with supplies (T10K); Cure Twist Female 12 Catheter Kit with supplies (T12K); Cure Twist Female 14 Catheter Kit with supplies (T14K); Cure Twist Female 16 Catheter Kit with supplies (T16K)	Jul 01, 2025	Substantially Equivalent	Convatec
K251116	Luja Coudé	Jun 27, 2025	Substantially Equivalent	Coloplast Corp.
K243175	Disposable Intermittent Catheter (TPU Catheter)	Jun 26, 2025	Substantially Equivalent	Chengdu Daxan Innovative Medical Tech. Co., Ltd.
K250270	Luja Set	Apr 17, 2025	Substantially Equivalent	Coloplast Corp.
K242049	SureCath Set	Nov 26, 2024	Substantially Equivalent	Coloplast Corp.
K241210	Luja Coude	Nov 21, 2024	Substantially Equivalent	Coloplast Corp.
K241028	Luja female (20051); Luja female (20052); Luja female (20054); Luja female (20056)	Jul 26, 2024	Substantially Equivalent	Coloplast
K233524	Sleeved IC 2 Family; Sleeved IC 2 SWT (Name not Finalized); Sleeved IC 2 Plus (Name not Finalized); Sleeved IC 2 Pocket (Name not Finalized); Sleeved IC 2 Plus Pocket (Name not Finalized)	May 03, 2024	Substantially Equivalent	Hollister Incorporated
K232665	GentleCath Air for Women (CH10); GentleCath Air for Women (CH12); GentleCath Air for Women (CH14)	Jan 25, 2024	Substantially Equivalent	Convatec
K230400	Cure Catheter Closed System; Cure Dextra Closed System	Nov 08, 2023	Unknown	Convatec, Inc.
K233101	Luja Coude (20108 Male CH18 - large packaging)	Oct 26, 2023	Substantially Equivalent	Coloplast Corp.
K230165	Luja Coudé (20118 Male CH8 - small packaging (Pocket size)), Luja Coudé (20111 Male CH10 - small packaging (Pocket size)), Luja Coudé (20112 Male CH12 - small packaging (Pocket size)), Luja Coudé (20114 Male CH14 - small packaging (Pocket size)), Luja Coudé (20101 Male CH10 - large packaging), Luja Coudé (20102 Male CH12 - large packaging), Luja Coudé (20104 Male CH14 - large packaging), Luja Coudé (20106 Male CH16 - large packaging)	Aug 25, 2023	Substantially Equivalent	Coloplast
K220722	PVC Hydrophilic Urethral Catheter	May 22, 2023	Substantially Equivalent	Well Lead Medical Co., Ltd.
K223756	SimPro Now, GentleCath Hydrophilic	May 04, 2023	Substantially Equivalent	Dentsply Sirona
K222677	Intermittent nelaton catheter for single use	Apr 05, 2023	Substantially Equivalent	Hangzhou Jimushi Meditech Co., Ltd.
K220667	Sleeved IC	Dec 08, 2022	Substantially Equivalent	Hollister Incorporated
K212567	PVC Hydrophilic Urethral Catheter	Dec 07, 2022	Substantially Equivalent	Chengdu Daxan Innovative Medical Tech. Co., Ltd.
K221401	Self-Cath and Self-Cath Plus	Dec 02, 2022	Substantially Equivalent	Coloplast
K221593	Cure Ultra Male, Cure Ultra Female, Cure Ultra Plus	Nov 17, 2022	Substantially Equivalent	Convatec, Inc.
K222059	SpeediCath Flex Set	Sep 21, 2022	Substantially Equivalent	Coloplast
K213575	Female IC (Not Finalized)	Sep 13, 2022	Substantially Equivalent	Hollister Incorporated
K212430	BONREE Nelaton Catheter	Apr 29, 2022	Substantially Equivalent	Bonree Medical Co., Ltd.
K210250	SpeedCath Compact Male	Apr 26, 2022	Substantially Equivalent	Coloplast
K203637	SpeediCath Compact (28578, 28580, 28582, 28584), SpeediCath Compact Plus (28810, 28812, 28814)	Mar 08, 2022	Substantially Equivalent	Coloplast
K211212	LoFric Elle	Feb 17, 2022	Substantially Equivalent	Dentsply Sirona
K202566	Wiygul Catheter	Sep 30, 2020	Substantially Equivalent	Big Blue Biotech, Inc.
K181445	AMSure Hydrophilic Intermittent Catheter	Oct 01, 2018	Substantially Equivalent	Amsino International, Inc.
K180738	COMPACTCATH Lubricated Intermittent UrinaryCatheter and OneCath Intermittent Urinary Catheter	Jun 14, 2018	Substantially Equivalent	Compactcath, Inc.
K172541	Medline Catheter Specimen Collector	Feb 22, 2018	Substantially Equivalent	Medline Industries, Inc.
K170233	Diposable Urinary Catheter (PVC Urinary Catheter, Silicone Urinary Catheter, Latex Urinary Catheter)	Oct 13, 2017	Substantially Equivalent	Zhanjiang Star Enterprise Co., Ltd.
K172247	Magic3 Go Intermittent Urinary Catheter	Sep 20, 2017	Substantially Equivalent	C.R. Bard, Inc.
K161445	PerfIC Cath Gel S, PerfIC Cath Gel C, PerfIC Cath Hydro S, PerfIC Cath Hydro C	Aug 16, 2016	Substantially Equivalent	Adapta Medical, Inc.
K160858	CompactCath Intermittent Urinary Catheter	Apr 26, 2016	Substantially Equivalent	Compactcath, Inc.
K151745	FULL CARE Disposable PVC Nelaton Catheter	Mar 03, 2016	Substantially Equivalent	Shaoxing Fuqing Health Products Co., Ltd.
K150345	Magic3 Go Intermittent Urinary Catheter	May 11, 2015	Substantially Equivalent	C.R. Bard, Inc.
K142575	Bard RiteCath Intermittent Urinary Catheter	Oct 31, 2014	Substantially Equivalent	C.R. Bard, Inc.
K142563	Well Lead PVC Urethral Catheter	Oct 28, 2014	Substantially Equivalent	Well Lead Medical Co., Ltd.
K140945	COMPACTCATH INTERMITTENT URINARY CATHETER	Aug 22, 2014	Substantially Equivalent	Compactcath, Inc.
K133470	BARD RITECATH INTERMITTENT CATHETER	Apr 04, 2014	Substantially Equivalent	C.R. Bard, Inc.
K133615	WELL LEAD PVC HYDROPHILIC URETHRAL CATHETER	Feb 24, 2014	Substantially Equivalent	Well Lead Medical Co., Ltd.
K132500	CURE CATHETER FEMALE, CURE CATHETER MALE, CURE CATHETER COUDE, CURE CATHETER PEDIATRIC, CURE CATHETER HYDROPHILIC COATED	Dec 23, 2013	Substantially Equivalent	Cure Medical, LLC
K132619	CLASSIC INTERMITTENT CATHETER	Oct 11, 2013	Substantially Equivalent	Flexicare Medical, Ltd.
K122785	HYDROSIL; MAGIC; PERSONAL CATHETER	May 14, 2013	Substantially Equivalent	Rochester Medical Corp.
K123751	LOFRIC SENSE	Feb 28, 2013	Substantially Equivalent	Wellspect Healthcare
K122078	LOFRIC PRIMO, LOFRIC HYDRO-KIT	Oct 31, 2012	Substantially Equivalent	Astra Tech, Inc.
K113424	LOFRIC SINGLE USE URINARY CATHETER	Apr 17, 2012	Substantially Equivalent	Astra Tech AB
K112137	COMFORTGLIDE INTERMITENT CATHETER	Aug 26, 2011	Unknown	C.R. Bard, Inc.
K110653	CURE CATHETER	Aug 01, 2011	Substantially Equivalent	Cure Medical, LLC
K103086	DYNAREX INTERMITTENT CATHETERS, MALE, FEMALE, PEDIATRIC	Jun 07, 2011	Substantially Equivalent	Dynarex Corporation
K103043	COLORADO CATHETER STERILESURE - NEW NAME PERFIC CATH	Jan 07, 2011	Substantially Equivalent	Adapta Medical, Inc.
K100302	MEDLINE PVC URETHRAL CATHETER	Jul 02, 2010	Substantially Equivalent	Medline Industries, Inc.
K100878	SELF CATH CATHETER	May 26, 2010	Substantially Equivalent	Coloplast Manufacturing Us, LLC
K091306	AMSURE PVC INTERMITTENT CATHETER	Aug 21, 2009	Substantially Equivalent	Amsino International, Inc.
K090576	FOOTPRINT URINARY DRAINAGE CATHETER	Aug 12, 2009	Substantially Equivalent	Footprint Medical
K080007	GRADUATED ADAPTER WITH CLAVE	May 13, 2008	Substantially Equivalent	Icu Medical, Inc.
K072997	NEOMED URINARY CATHETER	Dec 19, 2007	Substantially Equivalent	Neomed, Inc.
K072539	CURE CATHETER	Sep 13, 2007	Substantially Equivalent	Cure Medical, LLC
K061766	EXPRESSWAY INTERMITTENT CATHETER	Mar 09, 2007	Substantially Equivalent	Percutaneous Systems, Incorporated
K062444	HI-SLIP AND HI-SLIP PLUS SINGLE USE HYDROPHILIC URINARY CATHETERS AND KIT	Feb 22, 2007	Substantially Equivalent	Oasis Medikal Urunler Kimya Sanayi VE Tic A.S.
K052440	MENTOR SELF-CATH HYDROGEL INTERMITTENT CATHETER	Oct 11, 2005	Substantially Equivalent	Mentor Corporation
K050008	MENTOR SELF-CATH HYDROGEL INTERMITTENT CATHETER	Jun 03, 2005	Substantially Equivalent	Mentor Corp.
K041464	BUSSE HOSPITAL DISPOSABLES URETHRAL CATHETER	Nov 05, 2004	Substantially Equivalent	Busse Hospital Disposables
K040519	SLIP UROLOGY CATHETER	May 20, 2004	Substantially Equivalent	Percutaneous Systems, Inc.
K023872	VITALCARE URETHRAL CATHETER RED RUBBER	Apr 10, 2003	Substantially Equivalent	Vitalcare, Inc.
K030538	AMERICAN CATHETER, MODEL W3	Mar 10, 2003	Substantially Equivalent	Catheter, LLC
K993226	MEMCATH UROLOGY CATHETER, MODEL 101 -000 - 006	Dec 10, 1999	Substantially Equivalent	Memcath Technologies, LLC
K973546	KENDALL FAST-CATH PRE LUBRICATED URETHRAL CATHETER	Nov 07, 1997	Substantially Equivalent	Kendall Healthcare Products Co. Div.Of Tyco Health
K973070	CONVEEN EASICATH SET	Nov 06, 1997	Substantially Equivalent	Coloplast Corp.
K944383	ORION RED URETHRAL CATHETER	Dec 06, 1994	Substantially Equivalent	Regulatory & Marketing Services, Inc.
K944782	CATCO UROLOGICAL CATHETER	Oct 13, 1994	Substantially Equivalent	Catco Medical, Inc.
K923848	GOOSEN SELF-LUBRICATING CATHETER	Feb 18, 1994	Substantially Equivalent	Goosen Enterprises, Inc.
K931048	4-SURE NELATON CATHETER	Feb 14, 1994	Substantially Equivalent	Boston Pacific Medical, Inc.
K931047	4-SURE FEMALE CATHETER	Feb 14, 1994	Substantially Equivalent	Boston Pacific Medical, Inc.
K780411	TAYLOR CATHETER HOLDER	Apr 13, 1978	Substantially Equivalent	Taylor Catheter Holder Mfg.