Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Tyvek Sterilization Pouches with Chevron Seal

K-Number: K200336 · 2020-11-12

ApplicantAndersen Sterilizers, Inc.
Decision Date2020-11-12
Product CodeFRG
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Tyvek Sterilization Pouches with Chevron Seal is a medical device manufactured by Andersen Sterilizers, Inc.. It received FDA 510(k) clearance on 2020-11-12 under approval number K200336. 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 Tyvek Sterilization Pouches with Chevron Seal?

Tyvek Sterilization Pouches with Chevron Seal is a medical device that received FDA 510(k) clearance on 2020-11-12. It is manufactured by Andersen Sterilizers, Inc.. The 510(k) number is K200336.

When was Tyvek Sterilization Pouches with Chevron Seal approved by the FDA?

Tyvek Sterilization Pouches with Chevron Seal received FDA 510(k) clearance on 2020-11-12, under approval number K200336.

What company makes Tyvek Sterilization Pouches with Chevron Seal?

Tyvek Sterilization Pouches with Chevron Seal is manufactured by Andersen Sterilizers, Inc..

What is the FDA product code for Tyvek Sterilization Pouches with Chevron Seal?

The FDA product code for Tyvek Sterilization Pouches with Chevron Seal is FRG.

Other Devices by Andersen Sterilizers, Inc.

K170439AN87 Dosimeter K170437Sterisheet Sterilization Wrap K170427Anprolene SteriTest K170432Anprolene AN75 Ethylene Oxide Gas Sterilizer K170426AN85/AN86 EO Indicators K170429Tyvek Sterilization Pouches with Chevron Seal

View all 13 devices →

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

View on FDA Database →

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

↑