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FDA 510(k)

COOPERSURGICAL MODEL 6080 SMOKE EVACUATOR SYSTEM

K-Number: K910377 · 1991-04-19

ApplicantCooperSurgical, Inc.
Decision Date1991-04-19
Product CodeGCX
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

COOPERSURGICAL MODEL 6080 SMOKE EVACUATOR SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is CooperSurgical, Inc.. It received FDA 510(k) clearance on 1991-04-19 under 510(k) number K910377. The device is classified under product code GCX. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COOPERSURGICAL MODEL 6080 SMOKE EVACUATOR SYSTEM?

COOPERSURGICAL MODEL 6080 SMOKE EVACUATOR SYSTEM is a medical device that received FDA 510(k) clearance on 1991-04-19. The listed applicant is CooperSurgical, Inc.. The 510(k) number is K910377.

When did COOPERSURGICAL MODEL 6080 SMOKE EVACUATOR SYSTEM receive FDA 510(k) clearance?

COOPERSURGICAL MODEL 6080 SMOKE EVACUATOR SYSTEM received FDA 510(k) clearance on 1991-04-19, under 510(k) number K910377.

Who is the listed applicant for COOPERSURGICAL MODEL 6080 SMOKE EVACUATOR SYSTEM?

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

What is the FDA product code for COOPERSURGICAL MODEL 6080 SMOKE EVACUATOR SYSTEM?

The FDA product code for COOPERSURGICAL MODEL 6080 SMOKE EVACUATOR SYSTEM is GCX.

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Other records listing CooperSurgical, Inc. as applicant

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K261083Wallace® Aspiration Pump (WAPV1); Wallace® Pump Filter Connector (WFC); Wallace® Vacuum Connection Kit (WVCK)K243799Fetal PillowK250438CooperSurgical Milex® PessariesK223064ALLY II Uterine Positioning System™ (UPS)K201086Advincula Delineator Uterine ManipulatorK200038Endosee System

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Related Devices (Code: GCX)

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.

K042454STRYKER CASSETTE PUMPStryker EndoscopyK992126CIRCON SURGIFLEX WAVE TSUNAMI SUCTION-IRRIGATION SYSTEMCircon Corp.K972074SUCTION INSTRUMENTATIONWalter Lorenz Surgical, Inc.K971022CHASE SUCKERChase Medical, Inc.K964127MEDI-VAC FLEXI-CLEAR SUCTION HANDLEAllegiance Healthcare Corp.K964519CURITY THORACENTESIS TRAYKendall Healthcare Products Co. Div.Of Tyco Health

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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