Dukal Crepe Paper Sterilization Wrap— 510(k) K252823

Name: FDA 510(k) clearance K252823
Creator: U.S. Food and Drug Administration
Published: 2026-05-28

Substantially Equivalent

Dukal, LLC

FDA 510(k) clearance K252823 for Dukal Crepe Paper Sterilization Wrap, Substantially Equivalent on 2026-05-28. Applicant: Dukal, LLC. Device class: 2.

Summary

Dukal's Crepe Paper Sterilization Wrap is filed under FRG, sterilization wraps.

Class II, 21 CFR 880.6850. General Hospital is both the classification panel and the review panel, and it came in as a Traditional 510(k).

Dukal filed from Ronkonkoma, New York. Review took 266 calendar days (September 4, 2025 to May 28, 2026).

Clearance details

Applicant: Dukal, LLC
Product code: Product code FRG
Device class: Class 2
Regulation: 21 CFR 880.6850
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 ↗

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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.