FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
LaparoLight Veress Needle
K Number: K171139
·
Decision May 18, 2017
Classifications
1
FEI Numbers
141
Registration Numbers
141
Same Product Code
176
Applicant Total
2
Review Days
30
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Basic Information
- Device Name
- LaparoLight Veress Needle
- K Number
- K171139
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 884.1730
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Buffalo Filter, LLC
- Date Received
- April 18, 2017
- Decision Date
- May 18, 2017
- Product Code
- HIF
- Advisory Committee
- Obstetrics/Gynecology
- Review Advisory Committee
- OB
- Third Party
- Y
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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Other Clearances by Buffalo Filter, LLC
| K Number | Device Name | ||
|---|---|---|---|
| K150569 | LaparoVue | Jun 10, 2015 | Substantially Equivalent |