FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ORISE Tissue Retractor System
K Number: K173400
·
Decision Feb 9, 2018
Classifications
1
FEI Numbers
116
Registration Numbers
116
Same Product Code
100
Applicant Total
58
Review Days
101
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Basic Information
- Device Name
- ORISE Tissue Retractor System
- K Number
- K173400
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.1500
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Boston Scientific
- Date Received
- October 31, 2017
- Decision Date
- February 9, 2018
- Product Code
- FED
- 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 |
|---|---|---|---|
| FED | Endoscopic Access Overtube, Gastroenterology-Urology | FDA class 2 | Gastroenterology, Urology |
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