FDA 510(k)

BH Sterilization Pouch

K-Number: K172280 · 2018-08-03

Decision Date2018-08-03

Product CodeFRG

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

BH Sterilization Pouch is a medical device manufactured by Bh Medical Products Co., Ltd.. It received FDA 510(k) clearance on 2018-08-03 under approval number K172280. 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 BH Sterilization Pouch?

BH Sterilization Pouch is a medical device that received FDA 510(k) clearance on 2018-08-03. It is manufactured by Bh Medical Products Co., Ltd.. The 510(k) number is K172280.

When was BH Sterilization Pouch approved by the FDA?

BH Sterilization Pouch received FDA 510(k) clearance on 2018-08-03, under approval number K172280.

What company makes BH Sterilization Pouch?

BH Sterilization Pouch is manufactured by Bh Medical Products Co., Ltd..

What is the FDA product code for BH Sterilization Pouch?

The FDA product code for BH Sterilization Pouch is FRG.

Other Devices by Bh Medical Products Co., Ltd.

K190484BH Medical Dental Barrier Sleeves and Barrier Film

Related Devices (Code: FRG)

K160595PMSSteripack Tyvek Sterilization Pouch (TP) and Roll (TY) with Chemical IndicatorPms Medikal Ambalaj Sanayi VE Ticaret Ltd Sti K162162Barrier Supreme Sterilization WrapperStandard Textile Co., Inc. K153540Safe Secure Sterilization Pouch with Steam and Ethylene Oxide Process IndicatorsSafe Secure Packaging Co., Ltd. K160755Reliance Solo Sterilization Wrap, Reliance Tandem Sterilization WrapAhlstrom Nonwovens, LLC K160908Vis-U-All Low Temperature Sterilization Pouch/TubingSTERIS Corporation K152564Gemini Sterilization WrapMedline Industries, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.