System, Urine Drainage, Closed, For Nonindwelling Catheter, Sterile
The Sterile Closed Urine Drainage System for Nonindwelling Catheter (product code EYZ) is a sealed collection system used to collect urine from patients who are not retaining an indwelling catheter, helping to prevent infection. It is classified as FDA Class 1 (lowest risk), subject only to general controls, with no 510(k) submission required. The device is regulated under 21 CFR 876.5250 in the Gastroenterology and Urology specialty. No special flags apply.
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Basic Information
- Product Code
- EYZ
- Device Class
- FDA class 1
- Regulation Number
- 876.5250
- Medical Specialty
- Gastroenterology, Urology
- Review Panel
- GU
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 14 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K964219 | ZIP CONDOM CATHETER | Aug 11, 1997 | Substantially Equivalent | Goulter Medical, Inc. |
| K961906 | UNI-GARD QUIK CATH(SIZES 8 FRENCH THROUGH 18)UG 10008,10010,10012,10014,10016,10018 | Nov 19, 1996 | Substantially Equivalent | Spectrum Medsystems Corp. |
| K952780 | URINARY GEL DRAINAGE SYSTEM | Dec 12, 1995 | Substantially Equivalent | P.A.M., Inc. |
| K951597 | URINARY DRAINAGE BAG | Aug 04, 1995 | Substantially Equivalent | Key Medical Services, Inc. |
| K942753 | ONE STEP SPECIMEN COLLECTOR/TRANSPORT CONTAINER | Nov 02, 1994 | Substantially Equivalent | Researched, Novel Medical Devices (Rn/Md) |
| K933126 | COMFORTCARE SYSTEM | Feb 25, 1994 | Substantially Equivalent | Patsy J. Trisler, J.D. |
| K930556 | NIGHT URINARY DRAINAGE BEDSIDE BAG | May 14, 1993 | Substantially Equivalent | Ezmt Valve Co., Inc. |
| K896695 | DYNA-FLO URINARY DRAINAGE BAG | May 02, 1990 | Substantially Equivalent | Medline Industries, Inc. |
| K901000 | URO TEX URINALS | Mar 26, 1990 | Substantially Equivalent | Sierra Laboratories, Inc. |
| K891178 | TECNOL SECURE-ALL TUBE HOLDER | May 23, 1989 | Substantially Equivalent | Tecnol New Jersey Wound Care, Inc. |
| K890465 | CLOSED SYSTEM URINARY DRAINAGE BAG | May 23, 1989 | Substantially Equivalent | Cypress Medical Products, Ltd. |
| K882714 | URINARY DRAIN BAG, LSL CAT. NO. 1425 AND 1450 | Jan 31, 1989 | Substantially Equivalent | Lsl Industries, Inc. |
| K780267 | CATH TRAY W/OUT CATHETER | Feb 24, 1978 | Substantially Equivalent | Latex Ind., Inc. |
| K772113 | URINARY DRAINAGE BAG 2D9017 | Nov 16, 1977 | Substantially Equivalent | Travenol Laboratories, S.A. |
FEI Numbers
This FDA classification entry is associated with 49 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 49 registration numbers. Click on an entry to view related FDA registrations.