WARMTOUCH SURGICAL ACCESS BLANKET, WARMTOUCH TORSO BLANKET— 510(k) K131361

Substantially Equivalent

Covidien

FDA 510(k) clearance K131361 for WARMTOUCH SURGICAL ACCESS BLANKET, WARMTOUCH TORSO BLANKET, Substantially Equivalent on 2013-07-29. Applicant: Covidien.

Clearance details

Applicant: Covidien
Product code: Code DWJ
Advisory panel: Cardiovascular
Date received: 2013-05-13
Decision date: 2013-07-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Boulder, CO, 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.