FDA 510(k)
FDA class 2
Substantially Equivalent
🇦🇺 Australia
InsufflatOR Needle
K Number: K142700
·
Decision Dec 19, 2014
Classifications
1
FEI Numbers
141
Registration Numbers
141
Same Product Code
176
Applicant Total
4
Review Days
88
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Basic Information
- Device Name
- InsufflatOR Needle
- K Number
- K142700
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 884.1730
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Gynetech Pty. , Ltd.
- Date Received
- September 22, 2014
- Decision Date
- December 19, 2014
- Product Code
- HIF
- 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 |
|---|---|---|---|
| HIF | Insufflator, Laparoscopic | FDA class 2 | Obstetrics/Gynecology |
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