DIRECT PERORAL CHOLANGIOSCOPY BALLOON
FDA 510(k) clearance K101095 · decided 2010-07-19
Clearance details
- K-number
- K101095
- Device name
- DIRECT PERORAL CHOLANGIOSCOPY BALLOON
- Applicant
- Wilson-Cook Medical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2010-04-20
- Decision date
- 2010-07-19
- Days to decision
- 90 days
- Clearance type
- Traditional
- Product code
- FGE
- Device class
- 2
- Regulation number
- 876.5010
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Winston Salem, NC, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| DPOC-15, Cholangioscopy Access Balloon, G54951, 15 mm, Rx only, Cook Medical, Winston-Sale recall (Z-0925-2011) | Cook Endoscopy | 2011-01-19 |
| DPOC-20, Direct Peroral Cholangioscopy Balloon, G54951, 20 mm/17 mL, Rx Only, Cook Medical recall (Z-0926-2011) | Cook Endoscopy | 2011-01-19 |