FDA 510(k)

SIGMA Sterilization Pouch and Roll

K-Number: K202462 · 2021-04-23

ApplicantSigma Medical Supplies Corporation

Decision Date2021-04-23

Product CodeFRG

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

SIGMA Sterilization Pouch and Roll is a medical device manufactured by Sigma Medical Supplies Corporation. It received FDA 510(k) clearance on 2021-04-23 under approval number K202462. 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 SIGMA Sterilization Pouch and Roll?

SIGMA Sterilization Pouch and Roll is a medical device that received FDA 510(k) clearance on 2021-04-23. It is manufactured by Sigma Medical Supplies Corporation. The 510(k) number is K202462.

When was SIGMA Sterilization Pouch and Roll approved by the FDA?

SIGMA Sterilization Pouch and Roll received FDA 510(k) clearance on 2021-04-23, under approval number K202462.

What company makes SIGMA Sterilization Pouch and Roll?

SIGMA Sterilization Pouch and Roll is manufactured by Sigma Medical Supplies Corporation.

What is the FDA product code for SIGMA Sterilization Pouch and Roll?

The FDA product code for SIGMA Sterilization Pouch and Roll is FRG.

Other Devices by Sigma Medical Supplies Corporation

K180672Sterilization Pouch/Roll Made with Tyvek

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.