3M Bair Hugger Universal Warming Gown made with Thinsulate Insulation— 510(k) K210605

Substantially Equivalent

3M Company

FDA 510(k) clearance K210605 for 3M Bair Hugger Universal Warming Gown made with Thinsulate Insulation, Substantially Equivalent on 2021-04-29. Applicant: 3M Company.

Clearance details

Applicant: 3M Company
Product code: Code DWJ
Advisory panel: Cardiovascular
Date received: 2021-03-01
Decision date: 2021-04-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Saint Paul, MN, 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.