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 the device name listed in this FDA 510(k) record. The listed applicant is Sigma Medical Supplies Corporation. It received FDA 510(k) clearance on 2021-04-23 under 510(k) 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. The listed applicant is Sigma Medical Supplies Corporation. The 510(k) number is K202462.

When did SIGMA Sterilization Pouch and Roll receive FDA 510(k) clearance?

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

Who is the listed applicant for SIGMA Sterilization Pouch and Roll?

The FDA 510(k) record lists Sigma Medical Supplies Corporation as the applicant. This does not by itself establish the device manufacturer.

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 records listing Sigma Medical Supplies Corporation 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.

K180672Sterilization Pouch/Roll Made with Tyvek K180661SIGMA Sterilization Pouch and Roll

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

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