SurroundScope System

Laparoscope, Gynecologic (and Accessories)

270Surgical Ltd.

The following data is part of a premarket notification filed by 270surgical Ltd. with the FDA for Surroundscope System.

Pre-market Notification Details

Device IDK210104
510k NumberK210104
Device Name:SurroundScope System
ClassificationLaparoscope, Gynecologic (and Accessories)
Applicant 270Surgical Ltd. 4 Arie Regev Street Netanya,  IL 4250212
ContactAvi Levy
CorrespondentJanice Hogan
Hogan Lovells US LLP 1735 Market Street Suite 2300 Philadelphia,  PA  19103
Product CodeHET  
CFR Regulation Number884.1720 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-01-14
Decision Date2021-07-08

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