SIGMA STERILIZATION POUCH & ROLL— 510(k) K102158

Name: FDA 510(k) clearance K102158
Creator: U.S. Food and Drug Administration
Published: 2011-08-02

Substantially Equivalent

Sigma Medical Supplies Corp.

FDA 510(k) clearance K102158 for SIGMA STERILIZATION POUCH & ROLL, Substantially Equivalent on 2011-08-02. Applicant: Sigma Medical Supplies Corp.. Device class: 2.

Clearance details

Applicant: Sigma Medical Supplies Corp.
Product code: Code FRG
Device class: Class 2
Regulation: 21 CFR 880.6850
Advisory panel: General Hospital
Date received: 2010-07-30
Decision date: 2011-08-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Kaohsiung, TW

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.