EndoGI S-Path Biliary Stent System
FDA 510(k) clearance K202477 · decided 2020-09-24
Clearance details
- K-number
- K202477
- Device name
- EndoGI S-Path Biliary Stent System
- Applicant
- Endo GI Medical
- Decision
- Substantially Equivalent
- Date received
- 2020-08-28
- Decision date
- 2020-09-24
- Days to decision
- 27 days
- Clearance type
- Special
- Product code
- FGE
- Device class
- 2
- Regulation number
- 876.5010
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Nazareth, IL
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.