FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
CLOSED SYSTEM URINARY DRAINAGE BAG
K Number: K890465
·
Decision May 23, 1989
Classifications
1
FEI Numbers
49
Registration Numbers
49
Same Product Code
13
Applicant Total
26
Review Days
112
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Basic Information
- Device Name
- CLOSED SYSTEM URINARY DRAINAGE BAG
- K Number
- K890465
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 876.5250
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Applicant
- Cypress Medical Products, Ltd.
- Date Received
- January 31, 1989
- Decision Date
- May 23, 1989
- Product Code
- EYZ
- Advisory Committee
- Gastroenterology, Urology
- Review Advisory Committee
- GU
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| EYZ | System, Urine Drainage, Closed, For Nonindwelling Catheter, Sterile | FDA class 1 | Gastroenterology, Urology |
Similar 510(k) Clearances
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Other Clearances by Cypress Medical Products, Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K021676 | CYPRESS MEDICAL PRODUCTS, LP DISPOSABLE VAGINAL SPECULUM, NON-METAL | Jul 12, 2002 | Substantially Equivalent |
| K012282 | STERILE POWDER FREE SYNTHETIC VINYL PATIENT EXAM GLOVE | Aug 6, 2001 | Substantially Equivalent |
| K972899 | CYPRESS MEDICAL PRODUCTS ANEROID SPHYGMOMANOMETER | Jul 7, 1998 | Substantially Equivalent |
| K972849 | ISOSAFE EARLOOP PROCEDURE MASK (BLUE, YELLOW) | May 28, 1998 | Substantially Equivalent |
| K972883 | ISOSAFE EARLOOP PROCEDURE MASK (BLUE, YELLOW) | Feb 26, 1998 | Substantially Equivalent |
| K952367 | CYPRESS MEDICAL PRODUCTS VINYL EXAMINATION GLOVE | Jul 5, 1995 | Substantially Equivalent |
| K950254 | CYPRESS MEDICAL PRODUCTS STERILE LATEX EXAMINATION GLOVE | Mar 31, 1995 | Substantially Equivalent |
| K950092 | CYPRESS MEDICAL PRODUCTS CATHETER (INSERTION) TRAY | Feb 27, 1995 | Unknown |
| K950109 | CYPRESS MEDICAL PRODUCTS CATHETER (INSERTION) TRAY/WITH OUT CATHETER | Feb 27, 1995 | Unknown |
| K945082 | CYPRESS MEDICAL PRODUCTS STETHOSCOPE | Dec 8, 1994 | Substantially Equivalent |