Medicom Sterilization Pouch and Reel— 510(k) K243431
Substantially EquivalentMedicom Asia-Pacific Holdings Ltd. Taiwan Branch.
FDA 510(k) clearance K243431 for Medicom Sterilization Pouch and Reel, Substantially Equivalent on 2025-02-21. Applicant: Medicom Asia-Pacific Holdings Ltd. Taiwan Branch..
Clearance details
- Applicant
- Medicom Asia-Pacific Holdings Ltd. Taiwan Branch.
- Product code
- Code FRG
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Yilan County, TW
Adverse events under product code FRG
product code FRG- Other
- 3
- Total
- 3
Source: openFDA MAUDE database, through . 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.