Tangent Single-Use Digital System: Tangent Single-Use Digital Catheter and Tangent Digital Controller
FDA 510(k) clearance K251170 · decided 2025-09-12
Clearance details
- K-number
- K251170
- Device name
- Tangent Single-Use Digital System: Tangent Single-Use Digital Catheter and Tangent Digital Controller
- Applicant
- Tangent Endoscopy, LLC
- Decision
- Substantially Equivalent
- Date received
- 2025-04-15
- Decision date
- 2025-09-12
- Days to decision
- 150 days
- Clearance type
- Traditional
- Product code
- FBN
- Device class
- 2
- Regulation number
- 876.1500
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Camden, DE, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Tangent Endoscopy, Tangent Single Use Digital Catheter. Model Numbers: (1) TNG4002-IND. (2 recall (Z-2209-2026) | TANGENT ENDOSCOPY, LLC | 2026-05-15 |