FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
USGI TRANSPORT ENDOSCOPIC ACCESS DEVICE
K Number: K072405
·
Decision Sep 13, 2007
Classifications
1
FEI Numbers
116
Registration Numbers
116
Same Product Code
100
Applicant Total
11
Review Days
17
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Basic Information
- Device Name
- USGI TRANSPORT ENDOSCOPIC ACCESS DEVICE
- K Number
- K072405
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 876.1500
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Usgi Medical
- Date Received
- August 27, 2007
- Decision Date
- September 13, 2007
- Product Code
- FED
- 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 |
|---|---|---|---|
| FED | Endoscopic Access Overtube, Gastroenterology-Urology | FDA class 2 | Gastroenterology, Urology |
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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 |
| K061276 | G-PROX ENDOSCOPIC GRASPER | Dec 6, 2006 | 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 |