CINCH-TYPE DISPOSABLE LIMB HOLDERS, MODEL 912025— 510(k) K010644

Substantially Equivalent

Skil-Care Corp.

FDA 510(k) clearance K010644 for CINCH-TYPE DISPOSABLE LIMB HOLDERS, MODEL 912025, Substantially Equivalent on 2001-05-18. Applicant: Skil-Care Corp..

Clearance details

Applicant: Skil-Care Corp.
Product code: Code FMQ
Advisory panel: General Hospital
Date received: 2001-03-05
Decision date: 2001-05-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Yonkers, NY, US

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Adverse events under product code FMQ

product code FMQ

Death: 8
Total: 8

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.