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FDA 510(k)

SELF SEAL STERILIZATION POUCH

K-Number: K023025 · 2003-03-04

ApplicantGranton Medical , Ltd.
Decision Date2003-03-04
Product CodeFRG
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

SELF SEAL STERILIZATION POUCH is the device name listed in this FDA 510(k) record. The listed applicant is Granton Medical , Ltd.. It received FDA 510(k) clearance on 2003-03-04 under 510(k) number K023025. 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 SEAL STERILIZATION POUCH?

SELF SEAL STERILIZATION POUCH is a medical device that received FDA 510(k) clearance on 2003-03-04. The listed applicant is Granton Medical , Ltd.. The 510(k) number is K023025.

When did SELF SEAL STERILIZATION POUCH receive FDA 510(k) clearance?

SELF SEAL STERILIZATION POUCH received FDA 510(k) clearance on 2003-03-04, under 510(k) number K023025.

Who is the listed applicant for SELF SEAL STERILIZATION POUCH?

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

What is the FDA product code for SELF SEAL STERILIZATION POUCH?

The FDA product code for SELF SEAL STERILIZATION POUCH is FRG.

Related Clinical Trials

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.

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Other records listing Granton Medical , 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.

K052665GRANTON MEDICAL 121-135 C SELF-SEAL STERILIZATION POUCHES

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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