FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ACESSA GUIDANCE HANDPIECE
K Number: K132184
·
Decision Apr 28, 2014
Classifications
1
FEI Numbers
23
Registration Numbers
23
Same Product Code
10
Applicant Total
4
Review Days
287
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Basic Information
- Device Name
- ACESSA GUIDANCE HANDPIECE
- K Number
- K132184
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 884.4160
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Halt Medical, Inc.
- Date Received
- July 15, 2013
- Decision Date
- April 28, 2014
- Product Code
- HFG
- 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 |
|---|---|---|---|
| HFG | Coagulator, Laparoscopic, Unipolar (And Accessories) | FDA class 2 | Obstetrics/Gynecology |
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