FCM · Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit)
Gastroenterology, Urology · 21 CFR 876.5130 · Class 2
Overview
| Product Code | FCM |
|---|---|
| Device Name | Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit) |
| 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 59)
Showing 20 most recent of 59 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| 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 | Jun 6, 2025 | SESK |
| K223821 | Self-Cath Closed System | Coloplast | Aug 2, 2023 | SESE |
| K082831 | AMSELF CLOSED CATHETERIZATION SYSTEM | Amsino International, Inc. | Oct 23, 2008 | SESE |
| K070939 | SELF-CATH CS CLOSED URINARY CATHETERIZATION SYSTEM | Coloplast Manufacturing Us, LLC | Jun 1, 2007 | SESE |
| K070048 | GUARDIAN CATHETER-INFANT URINARY COLLECTION KIT | Marian Medical, Inc. | Mar 15, 2007 | SESE |
| K030712 | AMSURE URETHRAL CATHETERIZATION TRAY | Amsino International, Inc. | May 23, 2003 | SESE |
| K030664 | AMSURE FOLEY INSERTION TRAY | Amsino International, Inc. | May 23, 2003 | SESE |
| K011055 | THE O'NEIL STERILE FIELD URINARY CATHETER KIT WITH PREP PADS | Go Medical Industries Pty. , Ltd. | Jun 6, 2001 | SESE |
| K010420 | RUSCH MMG/O'NEIL CATHETER | Rusch, Inc. | May 9, 2001 | SESE |
| K003873 | MENTOR SELF-CATH CLOSED SYSTEM | Mentor Corp. | Mar 29, 2001 | SESE |
| K002803 | THE O'NEIL STERILE FIELD URINARY CATHETER KIT | Go Medical Industries Pty. , Ltd. | Dec 27, 2000 | SESE |
| K983010 | SELF CATH SET/SAFETY CATH | Rusch Intl. | Feb 12, 1999 | SESE |
| K963993 | RUSCH SIMPLASTIC FOLEY CATHETERIZATION SET | Rusch, Inc. | Dec 17, 1996 | SESE |
| K962254 | NHMC URETHRAL CATHETERIZATION TRAY | National Healthcare Mfg. Corp. | Jul 29, 1996 | SESE |
| K962073 | URETHRAL CATHETERIZATION TRAY/UNIVERSAL URETHRAL CATH TRAY | Continental Medical Laboratories, Inc. | Jun 21, 1996 | SESE |
| K961442 | UNIVERSAL DRAINAGE TRAY | Customed, Inc. | May 9, 1996 | SESE |
| K960215 | CPR URETHRAL CATHETER TRAY | Custom Pack Reliability | Apr 1, 1996 | SESE |
| K960214 | CPR FOLEY CAHTETER KIT | Custom Pack Reliability | Apr 1, 1996 | SESE |
| K960566 | NHMC FOLEY CATHETERIZATION TRAY | National Healthcare Mfg. Corp. | Feb 29, 1996 | SESE |
| K951479 | CATHETERIZATION INSERTION PACK UROLOGICAL, STERILE, DISPOSABLE | Trinity Laboratories, Inc. | Jun 15, 1995 | SESE |
Top Applicants
- Latex Ind., Inc. — 8 clearances
- Concord Laboratories, Inc. — 5 clearances
- Orion Life Systems, Inc. — 5 clearances
- Amsino International, Inc. — 3 clearances
- Snyder Laboratories, Inc. — 3 clearances
