FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
AP 50/30 Insufflator with Insuflow Port
K Number: K170799
·
Decision Nov 14, 2017
Classifications
1
FEI Numbers
141
Registration Numbers
141
Same Product Code
176
Applicant Total
13
Review Days
242
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Basic Information
- Device Name
- AP 50/30 Insufflator with Insuflow Port
- K Number
- K170799
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 884.1730
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Lexion Medical, LLC
- Date Received
- March 17, 2017
- Decision Date
- November 14, 2017
- 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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Other Clearances by Lexion Medical, LLC
| K Number | Device Name | ||
|---|---|---|---|
| K191780 | AP50/30 Insufflator with Insuflow Port | Aug 28, 2019 | Substantially Equivalent |
| K140263 | INSUFLOW SYNERGY PORT, INSUFLOW SYNERGY XL PORT | Mar 5, 2014 | Substantially Equivalent |
| K132203 | PNEUVIEW XE VERYCLEAR GAS EVACUATION CANNULA | Sep 20, 2013 | Substantially Equivalent |
| K132204 | INSUFLOW SYNERGY XL PORT | Aug 22, 2013 | Substantially Equivalent |
| K120640 | INSUFLOW SYNERGY PORT | Jul 18, 2012 | Substantially Equivalent |
| K112357 | VESSEL GUARDIAN | Nov 10, 2011 | Substantially Equivalent |
| K102136 | VESSEL GUARDIAN | Sep 27, 2010 | Substantially Equivalent |
| K101320 | VASOVAPOR | Jun 24, 2010 | Substantially Equivalent |
| K091366 | INSUFLOW DEWHEART | Sep 3, 2009 | Substantially Equivalent |
| K090456 | INSUFLOW | Aug 26, 2009 | Substantially Equivalent |