KIMGUARD SMART-FOLD STERILIZATION WRAP— 510(k) K140963

Substantially Equivalent

Kimberly-Clark Corp.

FDA 510(k) clearance K140963 for KIMGUARD SMART-FOLD STERILIZATION WRAP, Substantially Equivalent on 2014-11-10. Applicant: Kimberly-Clark Corp..

Clearance details

Applicant: Kimberly-Clark Corp.
Product code: Code FRG
Advisory panel: General Hospital
Date received: 2014-04-15
Decision date: 2014-11-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Roswell, GA, 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.