FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Bioceptive Suction Cervical Retractor
K Number: K142204
·
Decision Dec 19, 2014
Classifications
1
FEI Numbers
21
Registration Numbers
21
Same Product Code
19
Applicant Total
1
Review Days
130
Basic Information
- Device Name
- Bioceptive Suction Cervical Retractor
- K Number
- K142204
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 884.4530
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Bioceptive Inc.
- Date Received
- August 11, 2014
- Decision Date
- December 19, 2014
- 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 |
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