Comfortcare System
FDA 510(k) K933126 · Patsy J. Trisler, J.D.
510(k) numberK933126
Submission
- Device name
- Comfortcare System
- Applicant
- Patsy J. Trisler, J.D.
Rockville, MD, US - Received
- June 28, 1993
- Decision date
- February 25, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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 |
| 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 |
| K890465 | Closed System Urinary Drainage BagEYZ · Traditional | Cypress Medical Products, Ltd. | 05/23/1989SE |
Questions and answers
When was Comfortcare System cleared by the FDA?
Comfortcare System (K933126) received a 510(k) decision of Substantially Equivalent on February 25, 1994, 242 days after the submission was received.
What is the product code of K933126?
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.