The following data is part of a premarket notification filed by Surgitools Pty Ltd. with the FDA for Colpowave™ Colpotomizer And Cervigrip™ Uterine Manipulator.
| Device ID | K161065 |
| 510k Number | K161065 |
| Device Name: | ColpoWave™ Colpotomizer And CerviGrip™ Uterine Manipulator |
| Classification | Culdoscope (and Accessories) |
| Applicant | Surgitools Pty Ltd. 231 Timberlane Dr. Woodvale, AU 6026 |
| Contact | Jai Singh |
| Correspondent | Elizabeth Pugh Emergo Global Consulting, LLC 816 Congress Avenue, Suite 1400 Austin, TX 78701 |
| Product Code | HEW |
| CFR Regulation Number | 884.1640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-04-15 |
| Decision Date | 2016-10-27 |
| Summary: | summary |