FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
G-LIX TISSUE GRASPER
K Number: K061268
·
Decision Jul 31, 2006
Classifications
1
FEI Numbers
153
Registration Numbers
153
Same Product Code
336
Applicant Total
11
Review Days
87
Basic Information
- Device Name
- G-LIX TISSUE GRASPER
- K Number
- K061268
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 884.1720
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- USGI MEDICAL
- Date Received
- May 5, 2006
- Decision Date
- July 31, 2006
- Product Code
- HET
- 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 |
|---|---|---|---|
| HET | Laparoscope, Gynecologic (And Accessories) | FDA class 2 | Obstetrics/Gynecology |
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Other Clearances by USGI MEDICAL
| K Number | Device Name | ||
|---|---|---|---|
| K103688 | G-PROX EZ ENDOSCOPIC GRASPER | Jan 14, 2011 | Substantially Equivalent |
| K102931 | G-CINCH SUTURE GRASPER | Dec 30, 2010 | Substantially Equivalent |
| K102916 | G-CATH TISSUE ANCHOR DELIVERY CATHETER | Oct 20, 2010 | Substantially Equivalent |
| K100251 | G-CATH TISSUE ANCHOR DELIVERY CATHETER, MODELS 205302, 205333 | Feb 17, 2010 | Substantially Equivalent |
| K093018 | G-PROX ENDOSCOPIC GRASPER, MODEL 205333 | Oct 7, 2009 | Substantially Equivalent |
| K072405 | USGI TRANSPORT ENDOSCOPIC ACCESS DEVICE | Sep 13, 2007 | Substantially Equivalent |
| K061276 | G-PROX ENDOSCOPIC GRASPER | Dec 6, 2006 | Substantially Equivalent |
| K061216 | USGI TRANSPORT ENDOSCOPIC GUIDE | May 15, 2006 | Substantially Equivalent |
| K051919 | MODIFICATION TO: USGI SHAPELOCK ENDOSCOPIC GUIDE | Jul 26, 2005 | Substantially Equivalent |
| K050253 | USGI SHAPELOCK ENDOSCOPIC GUIDE | Feb 28, 2005 | Substantially Equivalent |