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 |