CHURCHHILL LANCET— 510(k) K854760

Substantially Equivalent

Churchill Corp.

FDA 510(k) clearance K854760 for CHURCHHILL LANCET, Substantially Equivalent on 1986-01-03. Applicant: Churchill Corp..

Clearance details

Applicant: Churchill Corp.
Product code: Code FMK
Advisory panel: General, Plastic Surgery
Date received: 1985-11-27
Decision date: 1986-01-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Langhorne, PA, US

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Adverse events under product code FMK

product code FMK

Injury: 133
Malfunction: 1,278
Other: 1
Total: 1,412

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.