The following data is part of a premarket notification filed by 270surgical Ltd. with the FDA for Surroundscope System.
| Device ID | K210104 |
| 510k Number | K210104 |
| Device Name: | SurroundScope System |
| Classification | Laparoscope, Gynecologic (and Accessories) |
| Applicant | 270Surgical Ltd. 4 Arie Regev Street Netanya, IL 4250212 |
| Contact | Avi Levy |
| Correspondent | Janice Hogan Hogan Lovells US LLP 1735 Market Street Suite 2300 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 | 2021-01-14 |
| Decision Date | 2021-07-08 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07290116583006 | K210104 | 000 |
| 07290116582009 | K210104 | 000 |
| 07290116580005 | K210104 | 000 |