EZD · Catheter, Straight
Gastroenterology, Urology · 21 CFR 876.5130 · Class 2
Overview
| Product Code | EZD |
|---|---|
| Device Name | Catheter, Straight |
| Regulation | 21 CFR 876.5130 |
| Device Class | Class 2 |
| Review Panel | Gastroenterology, Urology |
| 3rd-Party Reviewable | Yes |
Identification
A urological catheter and accessories is a flexible tubular device that is inserted through the urethra and used to pass fluids to or from the urinary tract. This generic type of device includes radiopaque urological catheters, ureteral catheters, urethral catheters, coudé catheters, balloon retention type catheters, straight catheters, upper urinary tract catheters, double lumen female urethrographic catheters, disposable ureteral catheters, male urethrographic catheters, and urological catheter accessories including ureteral catheter stylets, ureteral catheter adapters, ureteral catheter holders, ureteral catheter stylets, ureteral catheterization trays, and the gastro-urological irrigation tray (for urological use).
Classification Rationale
(1) Class II (performance standards).(2) Class I for the ureteral stylet (guidewire), stylet for gastrourological catheter, ureteral catheter adapter, ureteral catheter connector, and ureteral catheter holder. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.
Recent Cleared Devices (20 of 81)
Showing 20 most recent of 81 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K260999 | LoFric Elle Pro | Wellspect AB | Apr 24, 2026 | SESE |
| K252943 | GentleCath Air for Men; GentleCath Glide Intermittent Catheter; GentleCath Air for Women | Convatec Limited | Apr 1, 2026 | SESE |
| K260502 | Liv Pre-lubricated Intermittent Catheter | HR Healthcare | Mar 12, 2026 | SESE |
| K251274 | EZ-Protect Hydrophilic Closed System Intermittent Catheter; EZ-Protect Hydrophilic Closed System Intermittent Catheter Kits | HR Healthcare | Jan 29, 2026 | SESK |
| K251178 | Ready to use Nelaton Catheter | Jamjoom Fullcare Corporation | Jan 2, 2026 | SESE |
| 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) | Hollister Incorporated | Oct 3, 2025 | SESE |
| K250659 | LoFric Origo | Wellspect AB | Sep 26, 2025 | SESE |
| 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) | Convatec | Jul 1, 2025 | SESE |
| K251116 | Luja Coudé | Coloplast Corp. | Jun 27, 2025 | SESE |
| K243175 | Disposable Intermittent Catheter (TPU Catheter) | Chengdu Daxan Innovative Medical Tech. Co., Ltd. | Jun 26, 2025 | SESE |
| K250270 | Luja Set | Coloplast Corp. | Apr 17, 2025 | SESE |
| K242049 | SureCath Set | Coloplast Corp. | Nov 26, 2024 | SESE |
| K241210 | Luja Coude | Coloplast Corp. | Nov 21, 2024 | SESE |
| K241028 | Luja female (20051); Luja female (20052); Luja female (20054); Luja female (20056) | Coloplast | Jul 26, 2024 | SESE |
| 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) | Hollister Incorporated | May 3, 2024 | SESE |
| K232665 | GentleCath Air for Women (CH10); GentleCath Air for Women (CH12); GentleCath Air for Women (CH14) | Convatec | Jan 25, 2024 | SESE |
| K230400 | Cure Catheter Closed System; Cure Dextra Closed System | Convatec, Inc. | Nov 8, 2023 | SESK |
| K233101 | Luja Coude (20108 Male CH18 - large packaging) | Coloplast Corp. | Oct 26, 2023 | SESE |
| 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) | Coloplast | Aug 25, 2023 | SESE |
| K220722 | PVC Hydrophilic Urethral Catheter | Well Lead Medical Co., Ltd. | May 22, 2023 | SESE |
Top Applicants
- Coloplast — 6 clearances
- Coloplast Corp. — 6 clearances
- C.R. Bard, Inc. — 5 clearances
- Hollister Incorporated — 4 clearances
- Compactcath, Inc. — 3 clearances
