Usgi Medical
San Clemente, CA, US
USGI MEDICAL appears in FDA device records in San Clemente, CA. FDA records list 13 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 13 510(k) clearances for Usgi Medical between 2003 and 2011. The busiest year on record is 2006, with 3. The most recent is 2011, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2003 | 1 |
| 2004 | 1 |
| 2005 | 2 |
| 2006 | 3 |
| 2007 | 1 |
| 2009 | 1 |
| 2010 | 3 |
| 2011 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K103688 | G-PROX EZ ENDOSCOPIC GRASPER | OCZ | Substantially Equivalent | |
| K102931 | G-CINCH SUTURE GRASPER | OCW | Substantially Equivalent | |
| K102916 | G-CATH TISSUE ANCHOR DELIVERY CATHETER | GAT | Substantially Equivalent | |
| K100251 | G-CATH TISSUE ANCHOR DELIVERY CATHETER, MODELS 205302, 205333 | GAT | Substantially Equivalent | |
| K093018 | G-PROX ENDOSCOPIC GRASPER, MODEL 205333 | GAT | Substantially Equivalent | |
| K072405 | USGI TRANSPORT ENDOSCOPIC ACCESS DEVICE | FED | Substantially Equivalent | |
| K061276 | G-PROX ENDOSCOPIC GRASPER | GAT | Substantially Equivalent | |
| K061268 | G-LIX TISSUE GRASPER | HET | Substantially Equivalent | |
| K061216 | USGI TRANSPORT ENDOSCOPIC GUIDE | FED | Substantially Equivalent | |
| K051919 | MODIFICATION TO: USGI SHAPELOCK ENDOSCOPIC GUIDE | FED | Substantially Equivalent | |
| K050253 | USGI SHAPELOCK ENDOSCOPIC GUIDE | FED | Substantially Equivalent | |
| K033954 | SHAPE LOCKING ENDOSCOPIC OVERTUBE | FED | Substantially Equivalent | |
| K023902 | SHAPE-LOCKABLE ENDOSCOPIC OVERTUBE | FED | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3004447686 | 3004447686 | USGI MEDICAL | 1140 CALLE CORDILLERA, SAN CLEMENTE, CA 92673 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- FEDEndoscopic Access Overtube, Gastroenterology-Urology
- ODBEndoscopic Contamination Prevention Sheath
- OCZEndoscopic Grasping/Cutting Instrument, Non-Powered
- OCWEndoscopic Tissue Approximation Device
- HETLaparoscope, Gynecologic (And Accessories)
- GDWStaple, Implantable
- GATSuture, Nonabsorbable, Synthetic, Polyethylene
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain