Sterile Urethral Catheter Procedure Kits
FDA 510(k) K903340 · Superior Healthcare Group, Inc.
510(k) numberK903340
Submission
- Device name
- Sterile Urethral Catheter Procedure Kits
- Applicant
- Superior Healthcare Group, Inc.
Cumberland, RI, US - Received
- July 25, 1990
- Decision date
- October 4, 1990
- Decision
- Unknown (SESD)
- Type
- Traditional 510(k)
Device classification
- Product code
- FCM – Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.5130
- Specialty
- Gastroenterology, Urology
Other 510(k)s with product code FCM
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K254076 | BD Touchless Plus Unisex Pre-Lubricated Urethral Catheter KitFCM · Traditional | C.R. Bard, Inc. | 05/29/2026SESK |
| K250891 | Cure Catheter Insertion Kit (K1); Cure Catheter Insertion Kit (K2); Cure Catheter…FCM · Special | Convatec Limited | 06/06/2025SESK |
| K223821 | Self-Cath Closed SystemFCM · Traditional | Coloplast | 08/02/2023SE |
| K082831 | Amself Closed Catheterization SystemFCM · Special | Amsino International, Inc. | 10/23/2008SE |
| K070939 | Self-Cath CS Closed Urinary Catheterization SystemFCM · Special | Coloplast Manufacturing Us, LLC | 06/01/2007SE |
| K070048 | Guardian Catheter-Infant Urinary Collection KitFCM · Traditional | Marian Medical, Inc. | 03/15/2007SE |
| K030712 | Amsure Urethral Catheterization TrayFCM · Traditional | Amsino International, Inc. | 05/23/2003SE |
| K030664 | Amsure Foley Insertion TrayFCM · Traditional | Amsino International, Inc. | 05/23/2003SE |
| K011055 | The O'Neil Sterile Field Urinary Catheter Kit with Prep PadsFCM · Traditional | Go Medical Industries Pty. , Ltd. | 06/06/2001SE |
| K010420 | Rusch Mmg/O'Neil CatheterFCM · Traditional | Rusch, Inc. | 05/09/2001SE |
More from Rusch, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K925530 | Instrument WarmerFMS · Traditional | 06/18/1993SE |
| K924764 | Overtube for Endscopic LigatorMNK · Traditional | 03/15/1993SE |
| K905755 | Non-Sterile Patient Examination GlovesLYY · Traditional | 03/08/1991SE |
| K903347 | Sodium Chloride SolutionFOZ · Traditional | 12/13/1990SE |
| K904216 | Sterile Water Solution Catalog # 10000JOL · Traditional | 11/16/1990SE |
| K896321 | No. 34100 - 8 FR & No. 34400 - 14 FR Closed Trach.BSY · Traditional | 11/13/1989SE |
| K894676 | Sterile Latex Exam GlovesLYY · Traditional | 08/17/1989SE |
| K891445 | Latex Examination GlovesLYY · Traditional | 08/09/1989SE |
| K892426 | No. 86500 - Endoscopic Jet WasherOCX · Traditional | 06/22/1989SE |
| K885339 | Flow Thru 16,18,20,22 FR Replace. Gastro Tube KitKNT · Traditional | 03/01/1989SE |
Questions and answers
When was Sterile Urethral Catheter Procedure Kits cleared by the FDA?
Sterile Urethral Catheter Procedure Kits (K903340) received a 510(k) decision of Unknown on October 4, 1990, 71 days after the submission was received.
What is the product code of K903340?
The FDA product code is FCM – Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit), a Class II (moderate risk) device regulated under 21 CFR 876.5130.