STERILIZATION POUCH/ROLL MADE WITH TYVEK— 510(k) K133838

Substantially Equivalent

Sigma Medical Supplies Corp.

FDA 510(k) clearance K133838 for STERILIZATION POUCH/ROLL MADE WITH TYVEK, Substantially Equivalent on 2015-03-11. Applicant: Sigma Medical Supplies Corp..

Clearance details

Applicant: Sigma Medical Supplies Corp.
Product code: Code FRG
Advisory panel: General Hospital
Date received: 2013-12-18
Decision date: 2015-03-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Kaohsiung City, TW

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.