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FDA 510(k)

SPARCO SCOPE GUARD

K-Number: K850268 · 1985-04-15

ApplicantSparco, Inc.
Decision Date1985-04-15
Product CodeFEB
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

SPARCO SCOPE GUARD is the device name listed in this FDA 510(k) record. The listed applicant is Sparco, Inc.. It received FDA 510(k) clearance on 1985-04-15 under 510(k) number K850268. The device is classified under product code FEB. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SPARCO SCOPE GUARD?

SPARCO SCOPE GUARD is a medical device that received FDA 510(k) clearance on 1985-04-15. The listed applicant is Sparco, Inc.. The 510(k) number is K850268.

When did SPARCO SCOPE GUARD receive FDA 510(k) clearance?

SPARCO SCOPE GUARD received FDA 510(k) clearance on 1985-04-15, under 510(k) number K850268.

Who is the listed applicant for SPARCO SCOPE GUARD?

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

What is the FDA product code for SPARCO SCOPE GUARD?

The FDA product code for SPARCO SCOPE GUARD is FEB.

Related Clinical Trials

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Other records listing Sparco, 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.

K884041MASTER-GUARDK863964LIMB-GUARDK850267SPARCO PIGGY-BACK POLE-INTRAVENOUS TRANSPORT POLEK844286FLASH GUARD PLASTIC VERSIONK841669FLASH GUARD

Related Devices (Code: FEB)

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.

K241168System 83 Revolve Endoscope Washer/DisinfectorWassenburg Medical, Inc.K243433enspire 3000 Cleaning and Liquid Chemical Sterilant Processing SystemSTERIS CorporationK230930enspire 3000 Cleaning and Liquid Chemical Sterile Processing SystemSTERIS CorporationK213833SCOPE BUDDY PLUS Endoscope Flushing AidMedivators, Inc.K201920Endoscope Reprocessor OER-EliteOlympus Medical Systems Corp.K173590System 83 Plus Washer/DisinfectorCustom Ultrasonics, 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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