Gi Supply: FDA clearances and approvals
Gi Supply has 10 FDA 510(k) clearances (first 1992, latest 2023), across 7 product codes in 4 review panels. Median 510(k) review time: 118 days. Since 2017 its median was 338 days, against 143 days for all cleared 510(k)s in the same product codes. openFDA lists 1 product recall by a recalling firm named Gi Supply.
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 | 2 | 190 |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 1 | 376 |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, Gi Supply's cleared 510(k)s took a median 338 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 143 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| BTA | Pump, Portable, Aspiration (Manual Or Powered) | 2 | 2 |
| LYR | Helicobacter Pylori | 2 | 2 |
| PLL | Submucosal Injection Agent | 2 | 2 |
| EOQ | Bronchoscope (Flexible Or Rigid) | 1 | 1 |
| FGE | Stents, Drains And Dilators For The Biliary Ducts | 1 | 1 |
| LRO | General Surgery Tray | 1 | 1 |
| MNK | Endoscopic Bite Block | 1 | 1 |
Review panels
- Gastroenterology and Urology (4)
- General and Plastic Surgery (3)
- Microbiology (2)
- Ear, Nose and Throat (1)
Most recent Gi Supply 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K221042 | Renova RP Centesis Pump | BTA | 2023-04-19 | 376 |
| K202376 | EverLift Submucosal Lifting Agent | PLL | 2020-09-30 | 41 |
| K191923 | EverLift Submucosal Lifting Agent | PLL | 2020-06-20 | 338 |
| K031360 | GI SUPPLY BILIARY STENT | FGE | 2003-09-24 | 147 |
| K012411 | HP-ONE | LYR | 2001-09-25 | 57 |
| K970187 | RUNYON LARGE VOLUME PARACENTESIS KIT | LRO | 1997-02-14 | 28 |
| K970186 | GI SUPPLY PARACENTESIS PUMP | BTA | 1997-02-14 | 28 |
| K944903 | HP-FAST | LYR | 1995-04-20 | 198 |
| K931044 | OXY-BLOC | MNK | 1993-10-04 | 217 |
| K915816 | BITE BLOCK/MOUTHPIECE FOR ENDOSCOPY | EOQ | 1992-03-27 | 88 |
Recalls
1 product recalls in 1 recall events; 0 initiated in the last five years. Most recent: 2016-01-28.
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of Gi Supply's product codes (a text match, not an official crosswalk):
Frequently asked questions
How many FDA 510(k) clearances does Gi Supply have?
Gi Supply has 10 FDA 510(k) clearances (first 1992, latest 2023), across 7 product codes in 4 review panels.
How long does FDA take to clear Gi Supply's 510(k)s?
The median time from FDA receipt to decision across Gi Supply's cleared 510(k)s is 118 days. Since 2017: 338 days, versus 143 days for all cleared 510(k)s in the same product codes.
What devices does Gi Supply make?
Its most frequent FDA product codes are BTA (Pump, Portable, Aspiration (Manual Or Powered), 2); LYR (Helicobacter Pylori, 2); PLL (Submucosal Injection Agent, 2).
Has Gi Supply had device recalls?
openFDA lists 1 product recall in 1 recall event by a recalling firm whose name matches Gi Supply; the most recent began 2016-01-28. Recall firm names are matched by name, so related entities filing under other names are not included.
Next steps
- See all 10 Gi Supply clearances with predicates and recalls
- Run predicate analysis for product code BTA, Gi Supply's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.