FDA 510(k)
FDA class 2
Substantially Equivalent
🇬🇧 United Kingdom
URIGLOW TRANSILLUMINATING URETERIC STENT MODEL
K Number: K943801
·
Decision Aug 15, 1995
Classifications
1
FEI Numbers
13
Registration Numbers
13
Same Product Code
9
Applicant Total
3
Review Days
377
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Basic Information
- Device Name
- URIGLOW TRANSILLUMINATING URETERIC STENT MODEL
- K Number
- K943801
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.4020
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Rocket of London, Ltd.
- Date Received
- August 3, 1994
- Decision Date
- August 15, 1995
- Product Code
- FCS
- 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 |
|---|---|---|---|
| FCS | Light, Catheter, Fiberoptic, Glass, Ureteral | FDA class 2 | Gastroenterology, Urology |
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