MULTIPURPOSE, NEPHROSTOMY AND BILIARY DRAINAGE CATHETERS
FDA 510(k) clearance K093392 · decided 2009-12-31
Clearance details
- K-number
- K093392
- Device name
- MULTIPURPOSE, NEPHROSTOMY AND BILIARY DRAINAGE CATHETERS
- Applicant
- Navilyst Medical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2009-10-30
- Decision date
- 2009-12-31
- Days to decision
- 62 days
- Clearance type
- Abbreviated
- Product code
- FGE
- Device class
- 2
- Regulation number
- 876.5010
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Marlborough, MA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Exodus(TM) 8F (2.7 mm)/ 35 cm Standard Loop Biliary Drainage Catheter with Hydrophilic Coa recall (Z-0647-2012) | Navilyst Medical, Inc | 2012-01-11 |
| Exodus(TM) 10 F (3.4 mm)/ 35 cm Standard Loop Biliary Drainage Catheter with Hydrophilic C recall (Z-0648-2012) | Navilyst Medical, Inc | 2012-01-11 |
| Exodus(TM) 8F (2.7 mm)/25 cm Standard Loop Multipurpose Drainage Catheter with Hydrophilic recall (Z-0015-2011) | Navilyst Medical, Inc | 2010-10-07 |