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FDA 510(k)

PRO-GUARD

K-Number: K830739 · 1983-03-29

ApplicantSurgicot, Inc.
Decision Date1983-03-29
Product CodeFRG
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

PRO-GUARD is the device name listed in this FDA 510(k) record. The listed applicant is Surgicot, Inc.. It received FDA 510(k) clearance on 1983-03-29 under 510(k) number K830739. 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 PRO-GUARD?

PRO-GUARD is a medical device that received FDA 510(k) clearance on 1983-03-29. The listed applicant is Surgicot, Inc.. The 510(k) number is K830739.

When did PRO-GUARD receive FDA 510(k) clearance?

PRO-GUARD received FDA 510(k) clearance on 1983-03-29, under 510(k) number K830739.

Who is the listed applicant for PRO-GUARD?

The FDA 510(k) record lists Surgicot, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PRO-GUARD?

The FDA product code for PRO-GUARD is FRG.

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Other records listing Surgicot, Inc. 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.

K962605PRO-GUARD DOUBLE-DUTY STERILIZATION WRAP (SINGLE USE)K931270SURGICLEAN ENZYMATIC INSTRUMENT CLEANERK863122ASSERT BIOLOGICAL/CHEMICAL INDICATOR 12 MONTH EXP.K855101ASSERT TM BIOLOGICAL/CHEMICAL INDICATORK854631ASSERT EO BIOLOGICAL TEST PACKK854902SURGICOT STEAM TEST PACK

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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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