STERILE BURNNET PRE-CUT (VARIOUS SIZES)— 510(k) K891459

Substantially Equivalent

Western Medical, Ltd.

FDA 510(k) clearance K891459 for STERILE BURNNET PRE-CUT (VARIOUS SIZES), Substantially Equivalent on 1989-05-26. Applicant: Western Medical, Ltd..

Clearance details

Applicant: Western Medical, Ltd.
Product code: Code NAD
Advisory panel: General, Plastic Surgery
Date received: 1989-03-15
Decision date: 1989-05-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Camarillo, CA, US

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Adverse events under product code NAD

product code NAD

Injury: 431
Malfunction: 11,935
Other: 1
Total: 12,367

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.