PROLASTIC SHEETING— 510(k) K954382

Substantially Equivalent

Pillar Surgical

FDA 510(k) clearance K954382 for PROLASTIC SHEETING, Substantially Equivalent on 1995-11-29. Applicant: Pillar Surgical.

Clearance details

Applicant: Pillar Surgical
Product code: Code MIB
Advisory panel: Ear, Nose, Throat
Date received: 1995-09-19
Decision date: 1995-11-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: La Jolla, CA, US

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Adverse events under product code MIB

product code MIB

Injury: 146
Total: 146

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.