PERIPATCH SHEET, MODELS 1.5P8, 1.5P16, 4P4, 4P6, 6P8 AND 10P16— 510(k) K040835

Substantially Equivalent

Pm Devices, Inc.

FDA 510(k) clearance K040835 for PERIPATCH SHEET, MODELS 1.5P8, 1.5P16, 4P4, 4P6, 6P8 AND 10P16, Substantially Equivalent on 2004-06-15. Applicant: Pm Devices, Inc..

Clearance details

Applicant: Pm Devices, Inc.
Product code: Code FTM
Advisory panel: General, Plastic Surgery
Date received: 2004-03-31
Decision date: 2004-06-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Richmond, Bc, CA

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Adverse events under product code FTM

product code FTM

Death: 17
Injury: 2,174
Total: 2,191

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.