Taewoong Medical Co., Ltd.
Gimpo-Si Gyeonggi, KR
TAEWOONG MEDICAL CO., LTD appears in FDA device records in Gimpo-Si Gyeonggi, KR. FDA records list 17 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show one recall for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 17 510(k) clearances for Taewoong Medical Co., Ltd. between 2005 and 2026. The busiest year on record is 2023, with 3. The most recent is 2026, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2005 | 1 |
| 2008 | 1 |
| 2009 | 1 |
| 2012 | 1 |
| 2013 | 1 |
| 2021 | 1 |
| 2022 | 2 |
| 2023 | 3 |
| 2024 | 1 |
| 2025 | 3 |
| 2026 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K260962 | Sphincterotome | KNS | Substantially Equivalent | |
| K252648 | Niti-S SPAXUS Stent | PCU | Substantially Equivalent | |
| K251123 | Niti-S Biliary Stent; Niti-S Biliary Slim M Stent | FGE | Unknown | |
| K243619 | Niti-S Esophageal Stent; Esophageal TTS Stent | ESW | Substantially Equivalent | |
| K250663 | Niti-S Duodenal Comfort Stent, Niti-S Colonic Comfort Stent | MUM | Substantially Equivalent | |
| K240522 | Esophageal TTS Stent | ESW | Substantially Equivalent | |
| K223067 | Niti-S Duodenal Stent; Niti-S Colonic Comfort Stent | MUM | Substantially Equivalent | |
| K223626 | Niti-S Biliary Speed D Stent | FGE | Unknown | |
| K223256 | Optimos™ Cystotome | KNS | Substantially Equivalent | |
| K221482 | Esophageal TTS Stent | ESW | Substantially Equivalent | |
| K221071 | Niti-S Biliary Slim M Stent | FGE | Unknown | |
| K211706 | Esophageal TTS Stent | ESW | Substantially Equivalent | |
| K123205 | ESOPHAGEAL TTS STENT | ESW | Substantially Equivalent | |
| K113551 | ESOPHAGEAL TTS STENT | ESW | Substantially Equivalent | |
| K080782 | NITI-S ESOPHAGEAL STENT | ESW | Substantially Equivalent | |
| K073667 | NITI-S BILIARY STENT | FGE | Unknown | |
| K041648 | NITI-S STENT & INTRODUCER, MODEL EOXXXX | ESW | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3003902943 | 3003902943 | TAEWOONG MEDICAL CO., LTD | 14 Gojeong-ro, Wolgot-myeon, Gimpo-Si Gyeonggi 10022 KR | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- OCYEndoscopic Guidewire, Gastroenterology-Urology
- FCLForceps, Biopsy, Non-Electric
- QXHGallbladder Drainage Stent And Delivery System
- PCUPancreatic Stent, Covered, Metallic, Removable
- ESWProsthesis, Esophageal
- FGXSnare, Non-Electrical
- MQRStent, Colonic, Metallic, Expandable
- MUMStent, Metallic, Expandable, Duodenal
- FGEStents, Drains And Dilators For The Biliary Ducts
- KNSUnit, Electrosurgical, Endoscopic (With Or Without Accessories)
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1229-2020 | Niti-S Esophageal Stent, REF ES1806F, ES1808F, ES1810F, ES1815F, ES2006B, ES2010B, ES1612B, ES1615B, ES1810B, ES1812B, ES1815B, ES1610F, ES1612F, ES1615F, ES2006F, ES2008F, ES2010F; Esophageal TTS Stent, REF: EST1806F, EST2012F, EST2012B, EST2015F, EST2008F, EST1808F, EST1814F, EST1810F, EST2010F | Misprinted IFUs shipped with esophageal stents | Class II | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain