FCM — Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit) Class II
FDA product code FCM covers "Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit)", a Class II medical device regulated under 21 CFR 876.5130. Submissions are reviewed by the Gastroenterology, Urology panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- FCM
- Device Class
- Class II
- Regulation Number
- 876.5130
- Submission Type
- Review Panel
- GU
- Medical Specialty
- Gastroenterology, Urology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K254076 | c.r. bard | BD Touchless Plus Unisex Pre-Lubricated Urethral Catheter Kit | May 29, 2026 |
| K250891 | convatec limited | Cure Catheter Insertion Kit (K1); Cure Catheter Insertion Kit (K2); Cure Cathete | June 6, 2025 |
| K223821 | coloplast | Self-Cath Closed System | August 2, 2023 |
| K082831 | amsino international | AMSELF CLOSED CATHETERIZATION SYSTEM | October 23, 2008 |
| K070939 | coloplast manufacturing us | SELF-CATH CS CLOSED URINARY CATHETERIZATION SYSTEM | June 1, 2007 |
| K070048 | marian medical | GUARDIAN CATHETER-INFANT URINARY COLLECTION KIT | March 15, 2007 |
| K030664 | amsino international | AMSURE FOLEY INSERTION TRAY | May 23, 2003 |
| K030712 | amsino international | AMSURE URETHRAL CATHETERIZATION TRAY | May 23, 2003 |
| K011055 | go medical industries pty. | THE O'NEIL STERILE FIELD URINARY CATHETER KIT WITH PREP PADS | June 6, 2001 |
| K010420 | rusch | RUSCH MMG/O'NEIL CATHETER | May 9, 2001 |
| K003873 | mentor | MENTOR SELF-CATH CLOSED SYSTEM | March 29, 2001 |
| K002803 | go medical industries pty. | THE O'NEIL STERILE FIELD URINARY CATHETER KIT | December 27, 2000 |
| K983010 | rusch intl | SELF CATH SET/SAFETY CATH | February 12, 1999 |
| K963993 | rusch | RUSCH SIMPLASTIC FOLEY CATHETERIZATION SET | December 17, 1996 |
| K962254 | national healthcare mfg | NHMC URETHRAL CATHETERIZATION TRAY | July 29, 1996 |
| K962073 | continental medical laboratories | URETHRAL CATHETERIZATION TRAY/UNIVERSAL URETHRAL CATH TRAY | June 21, 1996 |
| K961442 | customed | UNIVERSAL DRAINAGE TRAY | May 9, 1996 |
| K960215 | custom pack reliability | CPR URETHRAL CATHETER TRAY | April 1, 1996 |
| K960214 | custom pack reliability | CPR FOLEY CAHTETER KIT | April 1, 1996 |
| K960566 | national healthcare mfg | NHMC FOLEY CATHETERIZATION TRAY | February 29, 1996 |