ACCORDION
FDA 510(k) clearance K052048 · decided 2005-09-13
Clearance details
- K-number
- K052048
- Device name
- ACCORDION
- Applicant
- Percutaneous Systems, Incorporated
- Decision
- Substantially Equivalent
- Date received
- 2005-07-29
- Decision date
- 2005-09-13
- Days to decision
- 46 days
- Clearance type
- Traditional
- Product code
- FFL
- Device class
- 2
- Regulation number
- 876.4680
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Mountain View, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.