The following data is part of a premarket notification filed by 270surgical Ltd with the FDA for Wv1 Endoscope.
| Device ID | K190190 |
| 510k Number | K190190 |
| Device Name: | WV1 Endoscope |
| Classification | Laparoscope, Gynecologic (and Accessories) |
| Applicant | 270Surgical Ltd 4 Arie Regev Street Natanya, IL 4250212 |
| Contact | Avi Levy |
| Correspondent | Janice Hogan Hogan Lovells US LLP 1735 Market Street, Suite 230 Philadelphia, PA 19103 |
| Product Code | HET |
| CFR Regulation Number | 884.1720 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-02-01 |
| Decision Date | 2019-11-01 |