FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MODIFICATION TO AUTO-BAND LIGATOR
K Number: K083556
·
Decision Feb 19, 2009
Classifications
1
FEI Numbers
27
Registration Numbers
27
Same Product Code
14
Applicant Total
2
Review Days
79
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Basic Information
- Device Name
- MODIFICATION TO AUTO-BAND LIGATOR
- K Number
- K083556
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 876.4400
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Scandimed International
- Date Received
- December 2, 2008
- Decision Date
- February 19, 2009
- Product Code
- MND
- 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 |
|---|---|---|---|
| MND | Ligator, Esophageal | FDA class 2 | Gastroenterology, Urology |
Similar 510(k) Clearances
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Other Clearances by Scandimed International
| K Number | Device Name | ||
|---|---|---|---|
| K081142 | AUTO-BAND LIGATOR | May 16, 2008 | Substantially Equivalent |