GIS ENDOSCOPIC OPTICAL LENS— 510(k) K140295

Substantially Equivalent

Gi Scientific, LLC

FDA 510(k) clearance K140295 for GIS ENDOSCOPIC OPTICAL LENS, Substantially Equivalent on 2014-07-24. Applicant: Gi Scientific, LLC.

Clearance details

Applicant: Gi Scientific, LLC
Product code: Code FDS
Advisory panel: Gastroenterology, Urology
Date received: 2014-02-06
Decision date: 2014-07-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Newbury, NH, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code FDS

product code FDS

Death: 37
Injury: 863
Malfunction: 56,442
Other: 1
Total: 57,343

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.