COOK ENDOSCOPY ESOPHAGEAL DILATION BALLOON
FDA 510(k) clearance K061937 · decided 2006-12-01
Clearance details
- K-number
- K061937
- Device name
- COOK ENDOSCOPY ESOPHAGEAL DILATION BALLOON
- Applicant
- Cook Endoscopy
- Decision
- Substantially Equivalent
- Date received
- 2006-07-10
- Decision date
- 2006-12-01
- Days to decision
- 144 days
- Clearance type
- Traditional
- Product code
- KNQ
- Device class
- 2
- Regulation number
- 876.5365
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Winston-Salem, NC, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| WIZARD X-CELL PHOTODYNAMIC THERAPY BALLOON WITH FIBER OPTIC DIFFUSER (P020021) | Cook Endoscopy | 2003-08-01 |