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FDA 510(k)

ACUFLO, VACUUM-POWERED BODY FLUID SUCTION APPARA.

K-Number: K896134 · 1990-08-30

ApplicantGoosen Enterprises, Inc.
Decision Date1990-08-30
Product CodeGCX
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

ACUFLO, VACUUM-POWERED BODY FLUID SUCTION APPARA. is the device name listed in this FDA 510(k) record. The listed applicant is Goosen Enterprises, Inc.. It received FDA 510(k) clearance on 1990-08-30 under 510(k) number K896134. 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 ACUFLO, VACUUM-POWERED BODY FLUID SUCTION APPARA.?

ACUFLO, VACUUM-POWERED BODY FLUID SUCTION APPARA. is a medical device that received FDA 510(k) clearance on 1990-08-30. The listed applicant is Goosen Enterprises, Inc.. The 510(k) number is K896134.

When did ACUFLO, VACUUM-POWERED BODY FLUID SUCTION APPARA. receive FDA 510(k) clearance?

ACUFLO, VACUUM-POWERED BODY FLUID SUCTION APPARA. received FDA 510(k) clearance on 1990-08-30, under 510(k) number K896134.

Who is the listed applicant for ACUFLO, VACUUM-POWERED BODY FLUID SUCTION APPARA.?

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

What is the FDA product code for ACUFLO, VACUUM-POWERED BODY FLUID SUCTION APPARA.?

The FDA product code for ACUFLO, VACUUM-POWERED BODY FLUID SUCTION APPARA. is GCX.

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Goosen Enterprises, 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.

K923848GOOSEN SELF-LUBRICATING CATHETERK896579GOOSEN URINARY DRAINAGE SYSTEMK844889MENSINK-GOOSEN CATHETER

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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