PocketDoc Micro Wound Therapy System— 510(k) K200223

Substantially Equivalent

Pensar Medical, LLC

FDA 510(k) clearance K200223 for PocketDoc Micro Wound Therapy System, Substantially Equivalent on 2020-10-23. Applicant: Pensar Medical, LLC.

Clearance details

Applicant: Pensar Medical, LLC
Product code: Code OMP
Advisory panel: General, Plastic Surgery
Date received: 2020-01-29
Decision date: 2020-10-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Norco, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code OMP

product code OMP

Death: 31
Injury: 1,707
Malfunction: 4,047
Other: 1
Total: 5,786

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.