Data / Medical devices / United States / Usgi Medical
Usgi Medical: FDA-registered device maker in San Clemente, CA, United States, 4 510(k) clearances
Usgi Medical is registered with the FDA (registration 3004447686) in San Clemente, CA, United States. It lists 6 device types. The FDA files 4 510(k) clearances under its listings, the newest dated January 14, 2011. Registered through 2026. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 3004447686
- Address
- 1140 Calle Cordillera, San Clemente, CA, United States, 92673
- Owner or operator
- USGI MEDICAL (9060300)
- Roles
- Manufacturer
- First device listed
- December 22, 2006
- Registered through
- 2026
- Brand names listed
- G-LIX TISSUE GRASPER, SHAPELOCK TRANSPORT, g-Cath Tissue Anchor, g-Prox EZ Endoscopic Grasper
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Endoscopic Access Overtube, Gastroenterology-Urology | FED | 2 | Manufacturer | accessdata.fda.gov |
| Endoscopic Contamination Prevention Sheath | ODB | 2 | Manufacturer | accessdata.fda.gov |
| Endoscopic Grasping/Cutting Instrument, Non-Powered | OCZ | 2 | Manufacturer | accessdata.fda.gov |
| Laparoscope, Gynecologic (And Accessories) | HET | 2 | Manufacturer | accessdata.fda.gov |
| Staple, Implantable | GDW | 2 | Manufacturer | accessdata.fda.gov |
| Suture, Nonabsorbable, Synthetic, Polyethylene | GAT | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| January 14, 2011 | K103688 | G-PROX EZ ENDOSCOPIC GRASPER | OCZ | Substantially Equivalent | Usgi Medical | accessdata.fda.gov |
| October 20, 2010 | K102916 | G-CATH TISSUE ANCHOR DELIVERY CATHETER | GAT | Substantially Equivalent | Usgi Medical | accessdata.fda.gov |
| September 13, 2007 | K072405 | USGI TRANSPORT ENDOSCOPIC ACCESS DEVICE | FED | Substantially Equivalent | Usgi Medical | accessdata.fda.gov |
| July 31, 2006 | K061268 | G-LIX TISSUE GRASPER | HET | Substantially Equivalent | Usgi Medical | accessdata.fda.gov |
Compare with other makers
- All makers of Endoscopic Grasping/Cutting Instrument, Non-Powered
- All makers of Laparoscope, Gynecologic (And Accessories)
- All makers of Suture, Nonabsorbable, Synthetic, Polyethylene
- All makers of Staple, Implantable
- All makers of Endoscopic Contamination Prevention Sheath
- All makers of Endoscopic Access Overtube, Gastroenterology-Urology
Updated January 14, 2011. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.