Closed System Urinary Drainage Bag
FDA 510(k) K890465 · Cypress Medical Products, Ltd.
510(k) numberK890465
Submission
- Device name
- Closed System Urinary Drainage Bag
- Applicant
- Cypress Medical Products, Ltd.
Mc Henry, IL, US - Received
- January 31, 1989
- Decision date
- May 23, 1989
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- EYZ – System, Urine Drainage, Closed, For Nonindwelling Catheter, Sterile
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 876.5250
- Specialty
- Gastroenterology, Urology
Other 510(k)s with product code EYZ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K964219 | Zip Condom CatheterEYZ · Traditional | Goulter Medical, Inc. | 08/11/1997SE |
| K961906 | Uni-Gard Quik Cath(Sizes 8 French Through 18)UG 10008,10010,10012,10014,10016,10018EYZ · Traditional | Spectrum Medsystems Corp. | 11/19/1996SE |
| K952780 | Urinary Gel Drainage SystemEYZ · Traditional | P.A.M., Inc. | 12/12/1995SE |
| K951597 | Urinary Drainage BagEYZ · Traditional | Key Medical Services, Inc. | 08/04/1995SE |
| K942753 | One Step Specimen Collector/Transport ContainerEYZ · Traditional | Researched, Novel Medical Devices (Rn/Md) | 11/02/1994SE |
| K933126 | Comfortcare SystemEYZ · Traditional | Patsy J. Trisler, J.D. | 02/25/1994SE |
| K930556 | Night Urinary Drainage Bedside BagEYZ · Traditional | Ezmt Valve Co., Inc. | 05/14/1993SE |
| K896695 | Dyna-Flo Urinary Drainage BagEYZ · Traditional | Medline Industries, Inc. | 05/02/1990SE |
| K901000 | Uro Tex UrinalsEYZ · Traditional | Sierra Laboratories, Inc. | 03/26/1990SE |
| K891178 | Tecnol Secure-All Tube HolderEYZ · Traditional | Tecnol New Jersey Wound Care, Inc. | 05/23/1989SE |
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| 510(k) | Device | Decision |
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| 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 |
| K950109 | Cypress Medical Products Catheter (Insertion) Tray/With Out CatheterFCM · Traditional | 02/27/1995SESK |
| K950092 | Cypress Medical Products Catheter (Insertion) TrayFCM · Traditional | 02/27/1995SESK |
| K945082 | Cypress Medical Products StethoscopeLDE · Traditional | 12/08/1994SE |
Questions and answers
When was Closed System Urinary Drainage Bag cleared by the FDA?
Closed System Urinary Drainage Bag (K890465) received a 510(k) decision of Substantially Equivalent on May 23, 1989, 112 days after the submission was received.
What is the product code of K890465?
The FDA product code is EYZ – System, Urine Drainage, Closed, For Nonindwelling Catheter, Sterile, a Class I (low risk) device regulated under 21 CFR 876.5250.