FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
WORKING CHANNEL VALVE
K Number: K900781
·
Decision Apr 25, 1990
Classifications
1
FEI Numbers
75
Registration Numbers
75
Same Product Code
1
Applicant Total
13
Review Days
64
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Basic Information
- Device Name
- WORKING CHANNEL VALVE
- K Number
- K900781
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 876.1500
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Applicant
- Applied Urology, Inc.
- Date Received
- February 20, 1990
- Decision Date
- April 25, 1990
- Product Code
- FFY
- 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 |
|---|---|---|---|
| FFY | Adaptor, Bulbs, Miscellaneous, For Endoscope | FDA class 1 | Gastroenterology, Urology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (FFY), ordered by most recent decision date.
View allOther Clearances by Applied Urology, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K921838 | ACUCISE URETERAL CUTTING CATHETER | Feb 26, 1993 | Substantially Equivalent |
| K925282 | UROLOGICAL CATHETER AND ACCESSORIES | Jan 13, 1993 | Substantially Equivalent |
| K920695 | URETERAL STENT | Sep 23, 1992 | Substantially Equivalent |
| K915219 | URETHRAL ELECTRODE SHEATH | Jul 23, 1992 | Substantially Equivalent |
| K912093 | DISPOSABLE ASPIRATION IRRIGATION SYSTEM | Apr 24, 1992 | Substantially Equivalent |
| K920030 | SURESEAL ENDOSCOPIC VALVE | Mar 18, 1992 | Substantially Equivalent |
| K912656 | ENDOSCOPIC ELECTRODE | Sep 16, 1991 | Substantially Equivalent |
| K912903 | PERCUTANEOUS RETRACTOR KIT | Aug 16, 1991 | Substantially Equivalent |
| K905731 | FLEXIBLE ENDOSCOPIC ELECTRODE | Jan 31, 1991 | Substantially Equivalent |
| K903994 | URETEROPYELOGRAM CATH FOR RETROGRADE DYE INJECTION | Oct 19, 1990 | Substantially Equivalent |