Esophageal TTS Stent
FDA 510(k) clearance K240522 · decided 2024-03-22
Clearance details
- K-number
- K240522
- Device name
- Esophageal TTS Stent
- Applicant
- Taewoong Medical
- Decision
- Substantially Equivalent
- Date received
- 2024-02-23
- Decision date
- 2024-03-22
- Days to decision
- 28 days
- Clearance type
- Special
- Product code
- ESW
- Device class
- 2
- Regulation number
- 878.3610
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Gyeonggi-Do, KR
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.