ENDOSCOPIC PLICATION SYSTEM; EPS; PLICATOR
FDA 510(k) clearance K071553 · decided 2007-09-18
Clearance details
- K-number
- K071553
- Device name
- ENDOSCOPIC PLICATION SYSTEM; EPS; PLICATOR
- Applicant
- Ndo Surgical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2007-06-06
- Decision date
- 2007-09-18
- Days to decision
- 104 days
- Clearance type
- Traditional
- Product code
- ODE
- Device class
- 2
- Regulation number
- 876.1500
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Mansfield, MA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.