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FDA 510(k)

Medicom Sterilization Pouch and Reel

K-Number: K243431 · 2025-02-21

ApplicantMedicom Asia-Pacific Holdings Ltd. Taiwan Branch.
Decision Date2025-02-21
Product CodeFRG
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Medicom Sterilization Pouch and Reel is a medical device manufactured by Medicom Asia-Pacific Holdings Ltd. Taiwan Branch.. It received FDA 510(k) clearance on 2025-02-21 under approval number K243431. The device is classified under product code FRG. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Medicom Sterilization Pouch and Reel?

Medicom Sterilization Pouch and Reel is a medical device that received FDA 510(k) clearance on 2025-02-21. It is manufactured by Medicom Asia-Pacific Holdings Ltd. Taiwan Branch.. The 510(k) number is K243431.

When was Medicom Sterilization Pouch and Reel approved by the FDA?

Medicom Sterilization Pouch and Reel received FDA 510(k) clearance on 2025-02-21, under approval number K243431.

What company makes Medicom Sterilization Pouch and Reel?

Medicom Sterilization Pouch and Reel is manufactured by Medicom Asia-Pacific Holdings Ltd. Taiwan Branch..

What is the FDA product code for Medicom Sterilization Pouch and Reel?

The FDA product code for Medicom Sterilization Pouch and Reel is FRG.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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