FDA 510(k)
FDA class 2
Unknown
🇺🇸 United States
Gastric Sizing Balloon Catheter
K Number: K173355
·
Decision Nov 17, 2017
Classifications
1
FEI Numbers
228
Registration Numbers
229
Same Product Code
648
Applicant Total
175
Review Days
23
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Basic Information
- Device Name
- Gastric Sizing Balloon Catheter
- K Number
- K173355
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 876.5980
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Unknown
- Statement or Summary
- Summary
- Applicant
- Cook Incorporated
- Date Received
- October 25, 2017
- Decision Date
- November 17, 2017
- Product Code
- KNT
- 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 |
|---|---|---|---|
| KNT | Tubes, Gastrointestinal (And Accessories) | FDA class 2 | Gastroenterology, Urology |
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