Taewoong Medical Co., Ltd.: FDA filings under this applicant name
FDA lists 17 510(k) clearances under the applicant name “Taewoong Medical Co., Ltd.” (first 2005, latest 2026), across 5 product codes in 1 review panel. Median 510(k) review time under this name: 172 days. Since 2017 the median was 146 days, against 151 days for all cleared 510(k)s in the same product codes. 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 | 1 | 75 |
| 2013 | 1 | 362 |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 1 | 127 |
| 2022 | 2 | 44 |
| 2023 | 3 | 172 |
| 2024 | 1 | 28 |
| 2025 | 3 | 262 |
| 2026 | 2 | 132 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Taewoong Medical Co., Ltd. took a median 146 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 151 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| ESW | Prosthesis, Esophageal | 8 | 8 |
| FGE | Stents, Drains And Dilators For The Biliary Ducts | 4 | 4 |
| KNS | Unit, Electrosurgical, Endoscopic (With Or Without Accessories) | 2 | 2 |
| MUM | Stent, Metallic, Expandable, Duodenal | 2 | 2 |
| PCU | Pancreatic Stent, Covered, Metallic, Removable | 1 | 1 |
Review panels
Most recent Taewoong Medical Co., Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K260962 | Sphincterotome | KNS | 2026-05-21 | 59 |
| K252648 | Niti-S SPAXUS Stent | PCU | 2026-03-13 | 204 |
| K251123 | Niti-S Biliary Stent; Niti-S Biliary Slim M Stent | FGE | 2025-12-29 | 262 |
| K243619 | Niti-S Esophageal Stent; Esophageal TTS Stent | ESW | 2025-10-30 | 342 |
| K250663 | Niti-S Duodenal Comfort Stent, Niti-S Colonic Comfort Stent | MUM | 2025-03-31 | 26 |
| K240522 | Esophageal TTS Stent | ESW | 2024-03-22 | 28 |
| K223067 | Niti-S Duodenal Stent; Niti-S Colonic Comfort Stent | MUM | 2023-06-14 | 264 |
| K223626 | Niti-S Biliary Speed D Stent | FGE | 2023-05-26 | 172 |
| K223256 | Optimos Cystotome | KNS | 2023-04-05 | 166 |
| K221482 | Esophageal TTS Stent | ESW | 2022-06-22 | 30 |
7 earlier clearances. See the full list in Caduvo.
Recalls
1 product recalls in 1 recall events; 0 initiated in the last five years. Most recent: 2019-10-18.
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 Taewoong Medical Co., Ltd. is the lead sponsor of 6 device studies on ClinicalTrials.gov (1 active or recruiting). Most recent:
- NCT03983512: PULSTA Transcatheter Pulmonary Valve Pre-Approval Study (Active not recruiting, started 2019-10-07)
- NCT03110861: Pulsta® Transcatheter Pulmonary Valve Korean Multicenter Study (Completed, started 2017-03-22)
- NCT02730663: A Study to Evaluate the Effectiveness and Safety of EUS-guided Transluminal Drainage With 'Niti-S SPAXUS Stent' (Completed, started 2016-03-21)
- NCT02460432: Comparison of Drug Eluting Stent and Covered Metal Stent in Malignant Biliary Obstruction (MIRA III) (Completed, started 2015-05)
- NCT01041612: Comparing Covered Self-expandable Metallic Stent (SEMS) Above/Across the Sphincter of Oddi (Completed, started 2010-01)
Frequently asked questions
How many FDA 510(k) clearances are listed under Taewoong Medical Co., Ltd.?
FDA lists 17 510(k) clearances under the applicant name “Taewoong Medical Co., Ltd.” (first 2005, latest 2026), across 5 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Taewoong Medical Co., Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Taewoong Medical Co., Ltd. is 172 days. Since 2017: 146 days, versus 151 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Taewoong Medical Co., Ltd.?
The most frequent FDA product codes under this applicant name are ESW (Prosthesis, Esophageal, 8); FGE (Stents, Drains And Dilators For The Biliary Ducts, 4); KNS (Unit, Electrosurgical, Endoscopic (With Or Without Accessories), 2).
Next steps
- See all 17 Taewoong Medical Co., Ltd. clearances with predicates and recalls
- Run predicate analysis for product code ESW, Taewoong Medical Co., Ltd.'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.