EZL · Catheter, Retention Type, Balloon

Device class

Class II

Regulation 876.5130

Total clearances

2020-03-31 → 2026-08-05

Last 12 months

Unique sponsors

Classification details

Medical specialty

Gastroenterology, Urology

Review panel

Regulation number

876.5130

Implant

Life-sustain / support

GMP exempt

Third-party review

Trend

Clearance volume by quarter

Players

Top sponsors in this product code

Sponsor	Clearances	Last 12 mo	Most recent
Silq Technologies, Corp.	3	0	2024-01-23
Teleflex Medical Sdn. Bhd.	2	2	2026-08-05
Teleflexmedical, Inc.	2	0	2024-08-01
Pathway, LLC	1	0	2020-04-21
Coloplast Corp.	1	0	2024-04-15
Well Lead Medical Co., Ltd.	1	0	2021-04-08
H R Pharmaceuticals, Inc.	1	0	2020-03-31
Innocare Urologics, LLC	1	0	2024-09-18
The Flume Catheter Company, Ltd.	1	0	2021-11-03
Sentinel Medical Technologies, LLC	1	0	2024-04-17
Apollon Co., Ltd.	1	0	2020-12-30
Hangzhou Primecare Medical Co., Ltd.	1	0	2020-12-15
Potrero Medical, Inc.	1	0	2023-01-13
Guangdong Ecan Medical Co., Ltd.	1	0	2025-06-16
Flume Catheter Company, Ltd.	1	0	2023-06-29

Reimbursement

Likely billing codes (AI-inferred · verify with billing)

Healthcare providers using this device would typically bill under these HCPCS Level II (alphanumeric) or CPT (5-digit) codes. Mapping inferred from device function by Claude Haiku; official descriptions pulled from the CMS HCPCS April 2026 quarterly file where available. Always verify with billing/coding teams before relying on these.

Code	Type	Description	Confidence	Rationale
A4338	HCPCS	Indwelling catheter; foley type, two-way latex with coating (teflon, silicone, silicone elastomer, or hydrophilic, etc.), each ✓ CMS-verified description	High	HCPCS code for indwelling urinary catheter, Foley type, latex, each
51702	CPT	—	Medium	CPT code for catheterization with cystourethroscopy including urethral meatotomy

Pulse

Most recent 510(k) clearances

Date	K-number	Sponsor	Device
2026-08-05	K262056	Teleflex Medical Sdn. Bhd.	Rusch Latex Gold Foley Catheter
2026-01-20	K252537	Teleflex Medical Sdn. Bhd.	Rusch SoftSimplastic Foley Catheters
2025-06-16	K243011	Guangdong Ecan Medical Co., Ltd.	Silicone Urethral Catheter (Silicone Urethral Catheter)
2024-09-18	K241424	Innocare Urologics, LLC	InnoCare Specialty Foley Catheter
2024-08-01	K232469	Teleflexmedical, Inc.	Rüsch Latex Gold Foley Catheter
2024-04-17	K240057	Sentinel Medical Technologies, LLC	TraumaGuard Intra-abdominal Pressure Sensing System
2024-04-15	K233411	Coloplast Corp.	Folysil Silicone Catheter
2024-01-23	K233013	Silq Technologies Corporation	2-Way 100% Silicone Cleartract Catheter
2023-07-27	K212077	Teleflexmedical, Inc.	Teleflex Rusch SoftSimplastic Foley Catheters
2023-06-29	K231101	Flume Catheter Company, Ltd.	Flume Catheter
2023-01-13	K221020	Potrero Medical, Inc.	Accuryn Monitoring System, Accuryn SmartFoley IAP UO Temp Tray System 12 F, Accuryn SmartFoley IAP UO Temp Tray System 14 F
2022-12-01	K222118	Silq Technologies, Corp.	2-Way 100% Silicone Cleartract Catheter
2022-07-01	K221625	Silq Technologies Corporation	2-Way 100% Silicone ClearTract Catheter
2021-11-03	K212151	The Flume Catheter Company, Ltd.	FLUME catheter
2021-04-08	K202134	Well Lead Medical Co., Ltd.	Well Lead All Silicone Foley Catheter with Temperature Sensor
2020-12-30	K201776	Apollon Co., Ltd.	Foley Balloon Catheter for Urology
2020-12-15	K202698	Hangzhou Primecare Medical Co., Ltd.	Prefilled Syringe
2020-04-21	K192034	Pathway, LLC	HDX 100% Silicone 2-way Foley Catheter, 14Fr/10cc, HDX 100% Silicone 2-way Foley Catheter, 16Fr/5cc, HDX 100% Silicone 2-way Foley Catheter, 18Fr/10cc
2020-03-31	K200556	H R Pharmaceuticals, Inc.	AquaFlate Pre-Filled Sterile Water Syringe 10mL