Cypress Medical Products Catheter (Insertion) Tray/With Out Catheter
FDA 510(k) K950109 · Cypress Medical Products, Ltd.
510(k) numberK950109
Submission
- Device name
- Cypress Medical Products Catheter (Insertion) Tray/With Out Catheter
- Applicant
- Cypress Medical Products, Ltd.
Mc Henry, IL, US - Received
- January 11, 1995
- Decision date
- February 27, 1995
- Decision
- Unknown (SESK)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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 |
|---|---|---|
| K021676 | Cypress Medical Products, LP Disposable Vaginal Speculum, Non-MetalHIB · Traditional | 07/12/2002SE |
| K012282 | Sterile Powder Free Synthetic Vinyl Patient Exam GloveLYZ · Traditional | 08/06/2001SE |
| K972899 | Cypress Medical Products Aneroid SphygmomanometerDXQ · Traditional | 07/07/1998SE |
| K972849 | Isosafe Earloop Procedure Mask (Blue, Yellow)FXX · Traditional | 05/28/1998SE |
| K972883 | Isosafe Earloop Procedure Mask (Blue, Yellow)FXX · Traditional | 02/26/1998SE |
| K952367 | Cypress Medical Products Vinyl Examination GloveLYY · Traditional | 07/05/1995SE |
| K950254 | Cypress Medical Products Sterile Latex Examination GloveLYY · Traditional | 03/31/1995SE |
| K950092 | Cypress Medical Products Catheter (Insertion) TrayFCM · Traditional | 02/27/1995SESK |
| K945082 | Cypress Medical Products StethoscopeLDE · Traditional | 12/08/1994SE |
| K921988 | Laceration Repair TrayMDM · Traditional | 11/19/1992SEKD |
Questions and answers
When was Cypress Medical Products Catheter (Insertion) Tray/With Out Catheter cleared by the FDA?
Cypress Medical Products Catheter (Insertion) Tray/With Out Catheter (K950109) received a 510(k) decision of Unknown on February 27, 1995, 47 days after the submission was received.
What is the product code of K950109?
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.