KIMGUARD ONE-STEP STERILIZATION WRAP, MODELS KC100, KC200, KC300, KC400, KC 500, KC600— 510(k) K091685

Name: FDA 510(k) clearance K091685
Creator: U.S. Food and Drug Administration
Published: 2009-09-03

Substantially Equivalent

Kimberly-Clark Corp.

FDA 510(k) clearance K091685 for KIMGUARD ONE-STEP STERILIZATION WRAP, MODELS KC100, KC200, KC300, KC400, KC 500, KC600, Substantially Equivalent on 2009-09-03. Applicant: Kimberly-Clark Corp.. Device class: 2.

Clearance details

Applicant: Kimberly-Clark Corp.
Product code: Code FRG
Device class: Class 2
Regulation: 21 CFR 880.6850
Advisory panel: General Hospital
Date received: 2009-06-10
Decision date: 2009-09-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Dawsonville, GA, 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.