FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PANAMEX(TM) URETERAL STENT
K Number: K882157
·
Decision Aug 2, 1988
Classifications
1
FEI Numbers
70
Registration Numbers
70
Same Product Code
121
Applicant Total
6
Review Days
71
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Basic Information
- Device Name
- PANAMEX(TM) URETERAL STENT
- K Number
- K882157
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.4620
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Applicant
- Kingston Technologies, Inc.
- Date Received
- May 23, 1988
- Decision Date
- August 2, 1988
- Product Code
- FAD
- 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 |
|---|---|---|---|
| FAD | Stent, Ureteral | FDA class 2 | Gastroenterology, Urology |
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Other Clearances by Kingston Technologies, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K935232 | HYDROTORQUE GUIDE WIRE | Jul 20, 1994 | Substantially Equivalent |
| K940814 | HYDRO-M(TM) WOUND GEL | May 12, 1994 | Substantially Equivalent |
| K940738 | KTI HY-Q(TM) WOUND DRESSING | May 6, 1994 | Substantially Equivalent for Some Indications |
| K925660 | KTI TRANSPARENT WOUND DRESSING | Apr 20, 1993 | Substantially Equivalent |
| K921502 | HYSORB WOUND DRESSING | Sep 29, 1992 | Substantially Equivalent |