OPT-SHIELD AIR, SUPINE; OPT-SHIELD, LITHOTOMY— 510(k) K162562

Substantially Equivalent

Bcg Medical, LLC

FDA 510(k) clearance K162562 for OPT-SHIELD AIR, SUPINE; OPT-SHIELD, LITHOTOMY, Substantially Equivalent on 2017-03-17. Applicant: Bcg Medical, LLC.

Clearance details

Applicant: Bcg Medical, LLC
Product code: Code DWJ
Advisory panel: Cardiovascular
Date received: 2016-09-14
Decision date: 2017-03-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Diego, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code DWJ

product code DWJ

Death: 7
Injury: 679
Malfunction: 17,477
Total: 18,163

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.