Medi-Globe Corp.: FDA filings under this applicant name
FDA lists 26 510(k) clearances under the applicant name “Medi-Globe Corp.” (first 1990, latest 2026), across 12 product codes in 2 review panels. Median 510(k) review time under this name: 165 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 | 2 | 101 |
| 2015 | 0 | — |
| 2016 | 1 | 189 |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 1 | 321 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Medi-Globe Corp. took a median 321 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 166 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| FCG | Biopsy Needle | 7 | 7 |
| FGE | Stents, Drains And Dilators For The Biliary Ducts | 6 | 6 |
| FBK | Endoscopic Injection Needle, Gastroenterology-Urology | 2 | 2 |
| FDI | Snare, Flexible | 2 | 2 |
| KNS | Unit, Electrosurgical, Endoscopic (With Or Without Accessories) | 2 | 2 |
| DRY | Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass | 1 | 1 |
| FCL | Forceps, Biopsy, Non-Electric | 1 | 1 |
| KGE | Forceps, Biopsy, Electric | 1 | 1 |
| LQC | Lithotriptor, Biliary Mechanical | 1 | 1 |
| LQR | Dislodger, Stone, Biliary | 1 | 1 |
Plus 2 more product codes.
Review panels
Most recent Medi-Globe Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K251658 | Endoflux Biliary & Pancreatic Stent Sets | FGE | 2026-04-16 | 321 |
| K153264 | EasyPass Guidewire | OCY | 2016-05-19 | 189 |
| K142258 | PolyCatch Retrieval Device | FDI | 2014-09-30 | 47 |
| K133763 | SONOTIP PRO AND PRO FLEX EBUS-TBNA NEEDLE SYSTEM | FCG | 2014-05-15 | 155 |
| K091257 | MEDI-GLOBE SONOTIP II EBUS-TBNA NEEDLE SYSTEM | FCG | 2009-05-08 | 9 |
| K083802 | SONOTIP II 25-GAUGE ULTRASOUND NEEDLE SYSTEM, MODELS GUS-01-18-025 AND GUS-01-27-025 | FCG | 2009-03-20 | 88 |
| K070129 | SONOTIP II ULTRASOUND NEEDLE SYSTEM | FCG | 2007-01-31 | 15 |
| K061222 | INJECTRA INJECTION NEEDLE | FBK | 2006-07-03 | 62 |
| K061684 | MEDI-GLOBE ROTA-CUT SPHINCTEROTOME | KNS | 2006-06-27 | 12 |
| K051247 | SONOTIP II ULTRASOUND NEEDLE SYSTEM | FCG | 2005-06-16 | 31 |
16 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Medi-Globe Corp..
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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Medi-Globe Corp.?
FDA lists 26 510(k) clearances under the applicant name “Medi-Globe Corp.” (first 1990, latest 2026), across 12 product codes in 2 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 Medi-Globe Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Medi-Globe Corp. is 165 days.
Which FDA product codes appear under Medi-Globe Corp.?
The most frequent FDA product codes under this applicant name are FCG (Biopsy Needle, 7); FGE (Stents, Drains And Dilators For The Biliary Ducts, 6); FBK (Endoscopic Injection Needle, Gastroenterology-Urology, 2).
Next steps
- See all 26 Medi-Globe Corp. clearances with predicates and recalls
- Run predicate analysis for product code FCG, Medi-Globe Corp.'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.