FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SRS ENDOSCOPIC STAPLING SYSTEM
K Number: K132151
·
Decision Mar 19, 2014
Classifications
1
FEI Numbers
11
Registration Numbers
11
Same Product Code
19
Applicant Total
4
Review Days
251
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Basic Information
- Device Name
- SRS ENDOSCOPIC STAPLING SYSTEM
- K Number
- K132151
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.1500
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Medigus , Ltd.
- Date Received
- July 11, 2013
- Decision Date
- March 19, 2014
- Product Code
- ODE
- 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 |
|---|---|---|---|
| ODE | Endoscopic Suture/Plication System, Gastroesophageal Reflux Disease (Gerd) | FDA class 2 | Gastroenterology, Urology |
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