Sterisheet Sterilization Wrap— 510(k) K152291

Name: FDA 510(k) clearance K152291
Creator: U.S. Food and Drug Administration
Published: 2015-12-17

Substantially Equivalent

Andersen Sterilizers, Inc.

FDA 510(k) clearance K152291 for Sterisheet Sterilization Wrap, Substantially Equivalent on 2015-12-17. Applicant: Andersen Sterilizers, Inc.. Device class: 2.

Clearance details

Applicant: Andersen Sterilizers, Inc.
Product code: Code FRG
Device class: Class 2
Regulation: 21 CFR 880.6850
Advisory panel: General Hospital
Date received: 2015-08-13
Decision date: 2015-12-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Haw River, NC, 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.