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FDA 510(k)

SteriTite Containers System & MediTray Products

K-Number: K161415 · 2017-02-10

ApplicantCase Medical, Inc.
Decision Date2017-02-10
Product CodeFRG
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

SteriTite Containers System & MediTray Products is the device name listed in this FDA 510(k) record. The listed applicant is Case Medical, Inc.. It received FDA 510(k) clearance on 2017-02-10 under 510(k) number K161415. 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 SteriTite Containers System & MediTray Products?

SteriTite Containers System & MediTray Products is a medical device that received FDA 510(k) clearance on 2017-02-10. The listed applicant is Case Medical, Inc.. The 510(k) number is K161415.

When did SteriTite Containers System & MediTray Products receive FDA 510(k) clearance?

SteriTite Containers System & MediTray Products received FDA 510(k) clearance on 2017-02-10, under 510(k) number K161415.

Who is the listed applicant for SteriTite Containers System & MediTray Products?

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

What is the FDA product code for SteriTite Containers System & MediTray Products?

The FDA product code for SteriTite Containers System & MediTray Products is FRG.

Other records listing Case Medical, Inc. 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.

K252854SteriTite Container System with MediTray ProductsK240898SteriTite rigid reusable sterilization container with MediTray ProductsK221492SteriTite Container System with MediTray PartsK212711SteriTite Container System with MediTray ProductsK173259Case Medical SteriTite Reusable Rigid Sterilization Container System with MediTray accessories

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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