FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
FEMTEN CERVICAL TENACULUM
K Number: K062563
·
Decision May 18, 2007
Classifications
1
FEI Numbers
23
Registration Numbers
23
Same Product Code
19
Applicant Total
2
Review Days
260
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Basic Information
- Device Name
- FEMTEN CERVICAL TENACULUM
- K Number
- K062563
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 884.4530
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Fem Suite, LLC
- Date Received
- August 31, 2006
- Decision Date
- May 18, 2007
- Product Code
- HDC
- 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 |
|---|---|---|---|
| HDC | Tenaculum, Uterine | FDA class 2 | Obstetrics/Gynecology |
Similar 510(k) Clearances
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Other Clearances by Fem Suite, LLC
| K Number | Device Name | ||
|---|---|---|---|
| K093218 | FEMEYE TWO | May 18, 2010 | Substantially Equivalent |