Sphincterotome
FDA 510(k) clearance K260962 · decided 2026-05-21
Clearance details
- K-number
- K260962
- Device name
- Sphincterotome
- Applicant
- Taewoong Medical Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2026-03-23
- Decision date
- 2026-05-21
- Days to decision
- 59 days
- Clearance type
- Traditional
- Product code
- KNS
- Device class
- 2
- Regulation number
- 876.4300
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Gimpo-Si, KR
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
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Recalls involving this device
No recalls on record reference this clearance.