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FDA 510(k)

Sterilization Pouch/Roll Made with Tyvek

K-Number: K180672 · 2018-06-06

ApplicantSigma Medical Supplies Corporation
Decision Date2018-06-06
Product CodeFRG
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Sterilization Pouch/Roll Made with Tyvek is a medical device manufactured by Sigma Medical Supplies Corporation. It received FDA 510(k) clearance on 2018-06-06 under approval number K180672. 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 Sterilization Pouch/Roll Made with Tyvek?

Sterilization Pouch/Roll Made with Tyvek is a medical device that received FDA 510(k) clearance on 2018-06-06. It is manufactured by Sigma Medical Supplies Corporation. The 510(k) number is K180672.

When was Sterilization Pouch/Roll Made with Tyvek approved by the FDA?

Sterilization Pouch/Roll Made with Tyvek received FDA 510(k) clearance on 2018-06-06, under approval number K180672.

What company makes Sterilization Pouch/Roll Made with Tyvek?

Sterilization Pouch/Roll Made with Tyvek is manufactured by Sigma Medical Supplies Corporation.

What is the FDA product code for Sterilization Pouch/Roll Made with Tyvek?

The FDA product code for Sterilization Pouch/Roll Made with Tyvek is FRG.

Other Devices by Sigma Medical Supplies Corporation

K202462SIGMA Sterilization Pouch and Roll

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.

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