FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SOPRO MODEL 640 LAPAROSCOPIC INSUFFLATOR
K Number: K070783
·
Decision Dec 13, 2007
Classifications
1
FEI Numbers
142
Registration Numbers
142
Same Product Code
174
Applicant Total
25
Review Days
267
Basic Information
- Device Name
- SOPRO MODEL 640 LAPAROSCOPIC INSUFFLATOR
- K Number
- K070783
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 884.1730
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- SOPRO
- Date Received
- March 21, 2007
- Decision Date
- December 13, 2007
- 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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|---|---|---|---|
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| K092329 | SOPIX 2 | Jul 20, 2010 | Substantially Equivalent |
| K092583 | SOPROLIFE | Jan 13, 2010 | Substantially Equivalent |
| K082796 | SOPRO 184 CAMERA | Apr 1, 2009 | Substantially Equivalent |
| K080122 | SOPRO 670 ARTHROSCOPIC PUMP | Jul 11, 2008 | Substantially Equivalent |
| K072912 | SOPRO 225 DUAL HALOGEN LIGHT SOURCE | Nov 16, 2007 | Substantially Equivalent |
| K070102 | SOPRO 162 CAMERA | Feb 20, 2007 | Substantially Equivalent |
| K031593 | SOPRO 61D | Sep 16, 2003 | Substantially Equivalent |