FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
GUARDIAN URETHRAL SHEATH
K Number: K131803
·
Decision Aug 20, 2013
Classifications
1
FEI Numbers
38
Registration Numbers
38
Same Product Code
63
Applicant Total
3
Review Days
62
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Basic Information
- Device Name
- GUARDIAN URETHRAL SHEATH
- K Number
- K131803
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 876.5130
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Solace Therapeutics
- Date Received
- June 19, 2013
- Decision Date
- August 20, 2013
- Product Code
- KNY
- 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 |
|---|---|---|---|
| KNY | Accessories, Catheter, G-U | FDA class 2 | Gastroenterology, Urology |
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