Dukal Crepe Paper Sterilization Wrap— 510(k) K252823

Substantially Equivalent

Dukal, LLC

FDA 510(k) clearance K252823 for Dukal Crepe Paper Sterilization Wrap, Substantially Equivalent on 2026-05-28. Applicant: Dukal, LLC.

Clearance details

Applicant: Dukal, LLC
Product code: Code FRG
Advisory panel: General Hospital
Date received: 2025-09-04
Decision date: 2026-05-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ronkonkoma, NY, US

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.