SterileRight sterilization pouch and roll— 510(k) K212338

Substantially Equivalent

Sterileright Packaging Mfg., Inc.

FDA 510(k) clearance K212338 for SterileRight sterilization pouch and roll, Substantially Equivalent on 2021-11-01. Applicant: Sterileright Packaging Mfg., Inc..

Clearance details

Applicant: Sterileright Packaging Mfg., Inc.
Product code: Code FRG
Advisory panel: General Hospital
Date received: 2021-07-27
Decision date: 2021-11-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Keelung 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.