FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MaxTack Motorized Fixation Device
K Number: K231240
·
Decision Sep 8, 2023
Classifications
1
FEI Numbers
52
Registration Numbers
52
Same Product Code
69
Applicant Total
130
Review Days
133
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Basic Information
- Device Name
- MaxTack Motorized Fixation Device
- K Number
- K231240
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.1500
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Covidien
- Date Received
- April 28, 2023
- Decision Date
- September 8, 2023
- Product Code
- OCW
- Advisory Committee
- Gastroenterology, Urology
- Review Advisory Committee
- SU
- 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 |
|---|---|---|---|
| OCW | Endoscopic Tissue Approximation Device | FDA class 2 | Gastroenterology, Urology |
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