Medicom Sterilization Pouch and Reel (K243431)
Description
Medicom Sterilization Pouch and Reel by Medicom Asia-Pacific Holdings Ltd. Taiwan Branch., an FDA 510(k) cleared general hospital device.
Regulatory Information
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K243431
A 510(k) clearance is granted by showing substantial equivalence to an earlier legally marketed device, called the predicate. This lineage is named in the 510(k) summary document and is not published by the FDA as a connected dataset. Medicom Sterilization Pouch and Reel (K243431) cites 1 predicate device and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K153540 | Safe Secure Sterilization Pouch with Steam and Ethylene Oxi... | Safe Secure Packaging Co., Ltd. | 2016 |
Trace the full predicate network for K243431
A link appears here only where the predicate could be read from a published 510(k) summary. Where no summary exists or a reference cannot be resolved to a K number, no link is drawn, so a gap means unknown rather than none.