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FDA 510(k)

Sterilization Pouch/Roll

K-Number: K251347 · 2026-01-28

ApplicantSterivic Medical Co., Ltd.
Decision Date2026-01-28
Product CodeFRG
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Sterilization Pouch/Roll is the device name listed in this FDA 510(k) record. The listed applicant is Sterivic Medical Co., Ltd.. It received FDA 510(k) clearance on 2026-01-28 under 510(k) number K251347. 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 Sterilization Pouch/Roll?

Sterilization Pouch/Roll is a medical device that received FDA 510(k) clearance on 2026-01-28. The listed applicant is Sterivic Medical Co., Ltd.. The 510(k) number is K251347.

When did Sterilization Pouch/Roll receive FDA 510(k) clearance?

Sterilization Pouch/Roll received FDA 510(k) clearance on 2026-01-28, under 510(k) number K251347.

Who is the listed applicant for Sterilization Pouch/Roll?

The FDA 510(k) record lists Sterivic Medical Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Sterilization Pouch/Roll?

The FDA product code for Sterilization Pouch/Roll 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.K251177Self-Seal Sterilization Pouch and RollGuangdong Maidi Medical Co., Ltd.K250306Chex-All Sterilization Pouches and TubesPropper Manufacturing Co., Inc.K243179Sterilization Pouch and RollYichang Xinxin Paper Products Co., Ltd.

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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