ESOPHAGEAL TTS STENT
FDA 510(k) clearance K123205 · decided 2013-10-09
Clearance details
- K-number
- K123205
- Device name
- ESOPHAGEAL TTS STENT
- Applicant
- Taewoong Medical Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2012-10-12
- Decision date
- 2013-10-09
- Days to decision
- 362 days
- Clearance type
- Traditional
- Product code
- ESW
- Device class
- 2
- Regulation number
- 878.3610
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Westminster, CO, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.