Gesco Intl., Inc.: FDA clearances and approvals
Gesco Intl., Inc. has 26 FDA 510(k) clearances (first 1978, latest 1995), across 18 product codes in 7 review panels. Median 510(k) review time: 86 days.
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 |
|---|---|---|---|
| FOS | Catheter, Umbilical Artery | 6 | 6 |
| LJS | Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days | 3 | 3 |
| JOL | Catheter And Tip, Suction | 2 | 2 |
| BSP | Needle, Conduction, Anesthetic (W/Wo Introducer) | 1 | 1 |
| BSY | Catheters, Suction, Tracheobronchial | 1 | 1 |
| BTR | Tube, Tracheal (W/Wo Connector) | 1 | 1 |
| DYB | Introducer, Catheter | 1 | 1 |
| FKO | Catheter, Peritoneal Dialysis, Single Use | 1 | 1 |
| FOZ | Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days | 1 | 1 |
| GBM | Catheter, Urethral | 1 | 1 |
Plus 8 more product codes.
Review panels
- General Hospital (12)
- Gastroenterology and Urology (4)
- Anesthesiology (3)
- General and Plastic Surgery (3)
- Cardiovascular (2)
- Neurology (1)
- Obstetrics and Gynecology (1)
Most recent Gesco Intl., Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K954422 | PER-Q-CATH MID-LINE | LJS | 1995-12-15 | 85 |
| K940953 | UMBILI-CATH-S | FOS | 1994-08-02 | 154 |
| K940870 | UMBILI-CATH | FOS | 1994-08-02 | 158 |
| K940952 | UMBILI-CATH-S-DL | FOS | 1994-07-29 | 150 |
| K941672 | URI-CATH CATHETER | GBM | 1994-05-16 | 41 |
| K941232 | THORA-CATH | JOL | 1994-05-11 | 57 |
| K940871 | UMBILI-CATH-P | FOS | 1994-04-29 | 63 |
| K931989 | VENTRI-CATH | JXG | 1993-07-21 | 90 |
| K926063 | PER-Q-CATH DRESSING CHANGE TRAY | MCY | 1993-06-07 | 188 |
| K923591 | PALA-NATE | BTR | 1993-03-16 | 239 |
16 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Gesco Intl., Inc..
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.
Frequently asked questions
How many FDA 510(k) clearances does Gesco Intl., Inc. have?
Gesco Intl., Inc. has 26 FDA 510(k) clearances (first 1978, latest 1995), across 18 product codes in 7 review panels.
How long does FDA take to clear Gesco Intl., Inc.'s 510(k)s?
The median time from FDA receipt to decision across Gesco Intl., Inc.'s cleared 510(k)s is 86 days.
What devices does Gesco Intl., Inc. make?
Its most frequent FDA product codes are FOS (Catheter, Umbilical Artery, 6); LJS (Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days, 3); JOL (Catheter And Tip, Suction, 2).
Has Gesco Intl., Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Gesco Intl., Inc. Related entities may recall under other names.
Next steps
- See all 26 Gesco Intl., Inc. clearances with predicates and recalls
- Run predicate analysis for product code FOS, Gesco Intl., Inc.'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.