Usgi Medical: FDA filings under this applicant name
FDA lists 13 510(k) clearances under the applicant name “Usgi Medical” (first 2003, latest 2011), across 5 product codes in 3 review panels. Median 510(k) review time under this name: 28 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| FED | Endoscopic Access Overtube, Gastroenterology-Urology | 6 | 6 |
| GAT | Suture, Nonabsorbable, Synthetic, Polyethylene | 4 | 4 |
| HET | Laparoscope, Gynecologic (And Accessories) | 1 | 1 |
| OCW | Endoscopic Tissue Approximation Device | 1 | 1 |
| OCZ | Endoscopic Grasping/Cutting Instrument, Non-Powered | 1 | 1 |
Review panels
Most recent Usgi Medical 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K103688 | G-PROX EZ ENDOSCOPIC GRASPER | OCZ | 2011-01-14 | 28 |
| K102931 | G-CINCH SUTURE GRASPER | OCW | 2010-12-30 | 87 |
| K102916 | G-CATH TISSUE ANCHOR DELIVERY CATHETER | GAT | 2010-10-20 | 19 |
| K100251 | G-CATH TISSUE ANCHOR DELIVERY CATHETER, MODELS 205302, 205333 | GAT | 2010-02-17 | 20 |
| K093018 | G-PROX ENDOSCOPIC GRASPER, MODEL 205333 | GAT | 2009-10-07 | 29 |
| K072405 | USGI TRANSPORT ENDOSCOPIC ACCESS DEVICE | FED | 2007-09-13 | 17 |
| K061276 | G-PROX ENDOSCOPIC GRASPER | GAT | 2006-12-06 | 212 |
| K061268 | G-LIX TISSUE GRASPER | HET | 2006-07-31 | 87 |
| K061216 | USGI TRANSPORT ENDOSCOPIC GUIDE | FED | 2006-05-15 | 13 |
| K051919 | MODIFICATION TO: USGI SHAPELOCK ENDOSCOPIC GUIDE | FED | 2005-07-26 | 11 |
3 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Usgi Medical.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Device clinical trials
An industry sponsor named Usgi Medical is the lead sponsor of 7 device studies on ClinicalTrials.gov (0 active or recruiting). Most recent:
- NCT05939973: A Feasibility Study for the Treatment of Primary Obesity Cross-over Arm (Completed, started 2023-01-19)
- NCT03721731: A Post-Market Surveillance Study of Using the g-Cath EZ for Treating Obesity (Completed, started 2018-09-18)
- NCT02279420: ESSENTIAL Trial™ Sham Cross-over (Completed, started 2015-01-05)
- NCT01958385: The USGI Medical ESSENTIAL Study for Weight Loss (Completed, started 2013-12-01)
- NCT01771276: ULTIMATE Study for Weight Loss (Completed, started 2012-06)
Frequently asked questions
How many FDA 510(k) clearances are listed under Usgi Medical?
FDA lists 13 510(k) clearances under the applicant name “Usgi Medical” (first 2003, latest 2011), across 5 product codes in 3 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Usgi Medical?
The median time from FDA receipt to decision across 510(k)s cleared under the name Usgi Medical is 28 days.
Which FDA product codes appear under Usgi Medical?
The most frequent FDA product codes under this applicant name are FED (Endoscopic Access Overtube, Gastroenterology-Urology, 6); GAT (Suture, Nonabsorbable, Synthetic, Polyethylene, 4); HET (Laparoscope, Gynecologic (And Accessories), 1).
Next steps
- See all 13 Usgi Medical clearances with predicates and recalls
- Run predicate analysis for product code FED, Usgi Medical's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.