FDA 510(k)

Sterisheet Sterilization Wrap

K-Number: K170437 · 2017-11-01

Decision Date2017-11-01

Product CodeFRG

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

Sterisheet Sterilization Wrap is the device name listed in this FDA 510(k) record. The listed applicant is Andersen Sterilizers, Inc.. It received FDA 510(k) clearance on 2017-11-01 under 510(k) number K170437. 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 Sterisheet Sterilization Wrap?

Sterisheet Sterilization Wrap is a medical device that received FDA 510(k) clearance on 2017-11-01. The listed applicant is Andersen Sterilizers, Inc.. The 510(k) number is K170437.

When did Sterisheet Sterilization Wrap receive FDA 510(k) clearance?

Sterisheet Sterilization Wrap received FDA 510(k) clearance on 2017-11-01, under 510(k) number K170437.

Who is the listed applicant for Sterisheet Sterilization Wrap?

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

What is the FDA product code for Sterisheet Sterilization Wrap?

The FDA product code for Sterisheet Sterilization Wrap is FRG.

Other records listing Andersen Sterilizers, 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.

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Related Devices (Code: FRG)

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, LLC K253454HALYARD* 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.