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FDA 510(k)

Self Sealing Sterilization Pouches

K-Number: K243721 · 2025-04-25

ApplicantWellmed Dental Medical Supply Co., Ltd.
Decision Date2025-04-25
Product CodeFRG
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Self Sealing Sterilization Pouches is the device name listed in this FDA 510(k) record. The listed applicant is Wellmed Dental Medical Supply Co., Ltd.. It received FDA 510(k) clearance on 2025-04-25 under 510(k) number K243721. 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 Self Sealing Sterilization Pouches?

Self Sealing Sterilization Pouches is a medical device that received FDA 510(k) clearance on 2025-04-25. The listed applicant is Wellmed Dental Medical Supply Co., Ltd.. The 510(k) number is K243721.

When did Self Sealing Sterilization Pouches receive FDA 510(k) clearance?

Self Sealing Sterilization Pouches received FDA 510(k) clearance on 2025-04-25, under 510(k) number K243721.

Who is the listed applicant for Self Sealing Sterilization Pouches?

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

What is the FDA product code for Self Sealing Sterilization Pouches?

The FDA product code for Self Sealing Sterilization Pouches is FRG.

Other records listing Wellmed Dental Medical Supply Co., Ltd. as applicant

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.

K242435Dental Barrier and SleevesK222697Disposable Medical Face Mask (DF3-001)

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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