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FDA 510(k)

SIGMA STERILIZATION POUCH & ROLL

K-Number: K102158 · 2011-08-02

ApplicantSigma Medical Supplies Corp.
Decision Date2011-08-02
Product CodeFRG
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

SIGMA STERILIZATION POUCH & ROLL is the device name listed in this FDA 510(k) record. The listed applicant is Sigma Medical Supplies Corp.. It received FDA 510(k) clearance on 2011-08-02 under 510(k) number K102158. 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 & ROLL?

SIGMA STERILIZATION POUCH & ROLL is a medical device that received FDA 510(k) clearance on 2011-08-02. The listed applicant is Sigma Medical Supplies Corp.. The 510(k) number is K102158.

When did SIGMA STERILIZATION POUCH & ROLL receive FDA 510(k) clearance?

SIGMA STERILIZATION POUCH & ROLL received FDA 510(k) clearance on 2011-08-02, under 510(k) number K102158.

Who is the listed applicant for SIGMA STERILIZATION POUCH & ROLL?

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

What is the FDA product code for SIGMA STERILIZATION POUCH & ROLL?

The FDA product code for SIGMA STERILIZATION POUCH & ROLL is FRG.

Related Clinical Trials

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.

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Other records listing Sigma Medical Supplies Corp. 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.

K180661SIGMA Sterilization Pouch and Roll

Related Devices (Code: FRG)

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.

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, LLCK253454HALYARD* 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

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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