HERCULES 3 STAGE WIRE GUIDED DILATION BALLOON
FDA 510(k) clearance K090183 · decided 2009-09-25
Clearance details
- K-number
- K090183
- Device name
- HERCULES 3 STAGE WIRE GUIDED DILATION BALLOON
- Applicant
- Cook Endoscopy
- Decision
- Substantially Equivalent
- Date received
- 2009-01-26
- Decision date
- 2009-09-25
- Days to decision
- 242 days
- Clearance type
- Special
- 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
+ Add to Predicate Builder ◉ Watch Cook Endoscopy
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
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 |