The following data is part of a premarket notification filed by Boston Scientific with the FDA for Symphion Endoscope And Symphion Cervical Sheath.
| Device ID | K160751 |
| 510k Number | K160751 |
| Device Name: | Symphion Endoscope And Symphion Cervical Sheath |
| Classification | Hysteroscope (and Accessories) |
| Applicant | BOSTON SCIENTIFIC 100 BOSTON SCIENTIFIC WAY Marlborough, MA 01752 |
| Contact | Brooke Cuddy |
| Correspondent | Brooke Cuddy BOSTON SCIENTIFIC 100 BOSTON SCIENTIFIC WAY Marlborough, MA 01752 |
| Product Code | HIH |
| CFR Regulation Number | 884.1690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-03-18 |
| Decision Date | 2016-06-14 |