FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
LAP LOOP
K Number: K092897
·
Decision Feb 1, 2010
Classifications
1
FEI Numbers
52
Registration Numbers
52
Same Product Code
43
Applicant Total
3
Review Days
133
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Basic Information
- Device Name
- LAP LOOP
- K Number
- K092897
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 884.4160
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Medsys, S.A.
- Date Received
- September 21, 2009
- Decision Date
- February 1, 2010
- Product Code
- KNF
- Advisory Committee
- Obstetrics/Gynecology
- Review Advisory Committee
- OB
- 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 |
|---|---|---|---|
| KNF | Coagulator-Cutter, Endoscopic, Unipolar (And Accessories) | FDA class 2 | Obstetrics/Gynecology |
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