FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
NITI-S ESOPHAGEAL STENT
K Number: K080782
·
Decision Jan 30, 2009
Classifications
1
FEI Numbers
31
Registration Numbers
31
Same Product Code
58
Applicant Total
16
Review Days
317
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Basic Information
- Device Name
- NITI-S ESOPHAGEAL STENT
- K Number
- K080782
- Device Class
- FDA class 2
- Clearance Type
- Abbreviated
- Regulation Number
- 878.3610
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Taewoong Medical Co., Ltd.
- Date Received
- March 19, 2008
- Decision Date
- January 30, 2009
- Product Code
- ESW
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- GU
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| ESW | Prosthesis, Esophageal | FDA class 2 | General, Plastic Surgery |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (ESW), ordered by most recent decision date.
Niti-S Esophageal Stent; Esophageal TTS Stent
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Resilience Fully Covered Esophageal Stent System
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Ultraflex Esophageal NG Stent System; WallFlex Esophageal Stent System
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Agile Esophageal Stent System
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Esophageal TTS Stent
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Other Clearances by Taewoong Medical Co., Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K260962 | Sphincterotome | May 21, 2026 | Substantially Equivalent |
| K252648 | Niti-S SPAXUS Stent | Mar 13, 2026 | Substantially Equivalent |
| K251123 | Niti-S Biliary Stent; Niti-S Biliary Slim M Stent | Dec 29, 2025 | Unknown |
| K243619 | Niti-S Esophageal Stent; Esophageal TTS Stent | Oct 30, 2025 | Substantially Equivalent |
| K250663 | Niti-S Duodenal Comfort Stent, Niti-S Colonic Comfort Stent | Mar 31, 2025 | Substantially Equivalent |
| K223067 | Niti-S Duodenal Stent; Niti-S Colonic Comfort Stent | Jun 14, 2023 | Substantially Equivalent |
| K223626 | Niti-S Biliary Speed D Stent | May 26, 2023 | Unknown |
| K223256 | Optimos Cystotome | Apr 5, 2023 | Substantially Equivalent |
| K221482 | Esophageal TTS Stent | Jun 22, 2022 | Substantially Equivalent |
| K221071 | Niti-S Biliary Slim M Stent | Jun 9, 2022 | Unknown |