FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
LSI SOLUTIONS FORNISEE SYSTEM UTERINE MANIPULATOR AND ACCESSORIES
K Number: K111014
·
Decision Jul 13, 2012
Classifications
1
FEI Numbers
23
Registration Numbers
23
Same Product Code
16
Applicant Total
2
Review Days
459
Basic Information
- Device Name
- LSI SOLUTIONS FORNISEE SYSTEM UTERINE MANIPULATOR AND ACCESSORIES
- K Number
- K111014
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 884.1640
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- LSI SOLUTIONS, INC.
- Date Received
- April 11, 2011
- Decision Date
- July 13, 2012
- Product Code
- HEW
- 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 |
|---|---|---|---|
| HEW | Culdoscope (And Accessories) | FDA class 2 | Obstetrics/Gynecology |
Similar 510(k) Clearances
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CooperSurgical Advincula Delineator Uterine Manipulator
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Other Clearances by LSI SOLUTIONS, INC.
| K Number | Device Name | ||
|---|---|---|---|
| K100593 | SUTURE PLACEMENT DEVICE AND ACCESSORIES, FLEXIBLE SUTURE PLACEMENT DEVICE AND ACCESSORIES, LSI R SERIES SUTURE PLACEME | Oct 13, 2010 | Substantially Equivalent |