PRIMED Sterilization Wrap (P100, P200, P300, P400, P500, P600)— 510(k) K242208

Substantially Equivalent

Primed Medical Products, Inc.

FDA 510(k) clearance K242208 for PRIMED Sterilization Wrap (P100, P200, P300, P400, P500, P600), Substantially Equivalent on 2024-10-07. Applicant: Primed Medical Products, Inc..

Clearance details

Applicant: Primed Medical Products, Inc.
Product code: Code FRG
Advisory panel: General Hospital
Date received: 2024-07-29
Decision date: 2024-10-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Edmonton, CA

Download summary PDF View on FDA.gov ↗

Adverse events under product code FRG

product code FRG

Other: 3
Total: 3

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.