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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 the device name listed in this FDA 510(k) record. The listed applicant is Medicom Asia-Pacific Holdings Ltd. Taiwan Branch.. It received FDA 510(k) clearance on 2025-02-21 under 510(k) 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. The listed applicant is Medicom Asia-Pacific Holdings Ltd. Taiwan Branch.. The 510(k) number is K243431.

When did Medicom Sterilization Pouch and Reel receive FDA 510(k) clearance?

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

Who is the listed applicant for Medicom Sterilization Pouch and Reel?

The FDA 510(k) record lists Medicom Asia-Pacific Holdings Ltd. Taiwan Branch. as the applicant. This does not by itself establish the device manufacturer.

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

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

Related Devices (Code: FRG)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261897HALYARD* ARMOR-FLEX* Sterilization Wrap with ASSURE-DRY* Technology; HALYARD* HEAVY-FLEX* Sterilization Wrap with ASSURE-DRY* Technology; HALYARD* STANDARD-FLEX* Sterilization Wrap with ASSURE-DRY* Technology; HALYARD* H300W Sterilization Wrap with ASSURE-DRY* TechnologyO&M Halyard, Inc.K252823Dukal Crepe Paper Sterilization WrapDukal, LLCK253454HALYARD* ONE-STEP* Sterilization Wrap; HALYARD* QUICK CHECK* Sterilization Wrap; HALYARD* SEQUENTIAL Sterilization Wrap; HALYARD* SMART-FOLD* Sterilization WrapO&M Halyard, Inc.K251347Sterilization Pouch/RollSterivic Medical Co., Ltd.K251177Self-Seal Sterilization Pouch and RollGuangdong Maidi Medical Co., Ltd.K250306Chex-All Sterilization Pouches and TubesPropper Manufacturing Co., Inc.

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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