SurroundScope System— 510(k) K210104

Substantially Equivalent

270surgical , Ltd.

FDA 510(k) clearance K210104 for SurroundScope System, Substantially Equivalent on 2021-07-08. Applicant: 270surgical , Ltd..

Clearance details

Applicant: 270surgical , Ltd.
Product code: Code HET
Advisory panel: Obstetrics/Gynecology
Date received: 2021-01-14
Decision date: 2021-07-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Netanya, IL

Download summary PDF View on FDA.gov ↗

Adverse events under product code HET

product code HET

Malfunction: 10,504
Total: 10,504

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.