FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
GASTROTOPO
K Number: K861291
·
Decision May 15, 1987
Classifications
1
FEI Numbers
137
Registration Numbers
137
Same Product Code
464
Applicant Total
3
Review Days
403
Basic Information
- Device Name
- GASTROTOPO
- K Number
- K861291
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5010
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Applicant
- HOUSTON BIOMEDICAL, INC.
- Date Received
- April 7, 1986
- Decision Date
- May 15, 1987
- Product Code
- FGE
- 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 |
|---|---|---|---|
| FGE | Stents, Drains And Dilators For The Biliary Ducts | FDA class 2 | Gastroenterology, Urology |
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