FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
INSUFLOW CO2IONSHIELD
K Number: K090879
·
Decision Jul 23, 2009
Classifications
1
FEI Numbers
33
Registration Numbers
33
Same Product Code
23
Applicant Total
13
Review Days
114
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Basic Information
- Device Name
- INSUFLOW CO2IONSHIELD
- K Number
- K090879
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.1500
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Lexion Medical, LLC
- Date Received
- March 31, 2009
- Decision Date
- July 23, 2009
- Product Code
- FCX
- Advisory Committee
- Gastroenterology, Urology
- Review Advisory Committee
- GU
- 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 |
|---|---|---|---|
| FCX | Insufflator, Automatic Carbon-Dioxide For Endoscope | FDA class 2 | Gastroenterology, Urology |
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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 |
| K170799 | AP 50/30 Insufflator with Insuflow Port | Nov 14, 2017 | 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 |