Symphion Endoscope and Symphion Cervical Sheath
FDA 510(k) clearance K160751 · decided 2016-06-14
Clearance details
- K-number
- K160751
- Device name
- Symphion Endoscope and Symphion Cervical Sheath
- Applicant
- Boston Scientific
- Decision
- Substantially Equivalent
- Date received
- 2016-03-18
- Decision date
- 2016-06-14
- Days to decision
- 88 days
- Clearance type
- Traditional
- Product code
- HIH
- Device class
- 2
- Regulation number
- 884.1690
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- Marlboro, MA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.