SELF SEAL STERILIZATION POUCH— 510(k) K023025

Substantially Equivalent

Granton Medical , Ltd.

FDA 510(k) clearance K023025 for SELF SEAL STERILIZATION POUCH, Substantially Equivalent on 2003-03-04. Applicant: Granton Medical , Ltd..

Clearance details

Applicant: Granton Medical , Ltd.
Product code: Code FRG
Advisory panel: General Hospital
Date received: 2002-09-11
Decision date: 2003-03-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Crofton, MD, US

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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.