FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
G-PROX ENDOSCOPIC GRASPER
K Number: K061276
·
Decision Dec 6, 2006
Classifications
1
FEI Numbers
242
Registration Numbers
242
Same Product Code
173
Applicant Total
11
Review Days
212
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Basic Information
- Device Name
- G-PROX ENDOSCOPIC GRASPER
- K Number
- K061276
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.5000
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Usgi Medical
- Date Received
- May 8, 2006
- Decision Date
- December 6, 2006
- Product Code
- GAT
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- SU
- 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 |
|---|---|---|---|
| GAT | Suture, Nonabsorbable, Synthetic, Polyethylene | FDA class 2 | General, Plastic Surgery |
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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 |
| K061268 | G-LIX TISSUE GRASPER | Jul 31, 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 |