SNUGGLE WARM 4000 CONVECTIVE WARMING SYSTEM, MODEL SW4000— 510(k) K040632

Substantially Equivalent

Smiths Medical Asd, Inc.

FDA 510(k) clearance K040632 for SNUGGLE WARM 4000 CONVECTIVE WARMING SYSTEM, MODEL SW4000, Substantially Equivalent on 2004-04-27. Applicant: Smiths Medical Asd, Inc..

Clearance details

Applicant: Smiths Medical Asd, Inc.
Product code: Code DWJ
Advisory panel: Cardiovascular
Date received: 2004-03-10
Decision date: 2004-04-27
Decision: Substantially Equivalent
Clearance type: Special
Location: Rockland, MA, US

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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.