Cleared Traditional

SurroundScope System

K210104 · 270surgical , Ltd. · Obstetrics & Gynecology

Jul 2021

Decision

175d

Days

Class 2

Risk

About This 510(k) Submission

K210104 is an FDA 510(k) clearance for the SurroundScope System, a Laparoscope, Gynecologic (and Accessories) (Class II — Special Controls, product code HET), submitted by 270surgical , Ltd. (Netanya, IL). The FDA issued a Cleared decision on July 8, 2021, 175 days after receiving the submission on January 14, 2021. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.1720.

Submission Details

510(k) Number	K210104 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 14, 2021
Decision Date	July 08, 2021
Days to Decision	175 days
Submission Type	Traditional
Review Panel	Obstetrics & Gynecology (OB)
Summary	Summary PDF