Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

MAXI-FLOW SUCTION TUBE/TOP GUN SUCTION IRRIGATOR

K-Number: K955151 · 1996-01-24

ApplicantBio-Medical Devices, Inc.
Decision Date1996-01-24
Product CodeBYY
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

MAXI-FLOW SUCTION TUBE/TOP GUN SUCTION IRRIGATOR is the device name listed in this FDA 510(k) record. The listed applicant is Bio-Medical Devices, Inc.. It received FDA 510(k) clearance on 1996-01-24 under 510(k) number K955151. The device is classified under product code BYY. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MAXI-FLOW SUCTION TUBE/TOP GUN SUCTION IRRIGATOR?

MAXI-FLOW SUCTION TUBE/TOP GUN SUCTION IRRIGATOR is a medical device that received FDA 510(k) clearance on 1996-01-24. The listed applicant is Bio-Medical Devices, Inc.. The 510(k) number is K955151.

When did MAXI-FLOW SUCTION TUBE/TOP GUN SUCTION IRRIGATOR receive FDA 510(k) clearance?

MAXI-FLOW SUCTION TUBE/TOP GUN SUCTION IRRIGATOR received FDA 510(k) clearance on 1996-01-24, under 510(k) number K955151.

Who is the listed applicant for MAXI-FLOW SUCTION TUBE/TOP GUN SUCTION IRRIGATOR?

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

What is the FDA product code for MAXI-FLOW SUCTION TUBE/TOP GUN SUCTION IRRIGATOR?

The FDA product code for MAXI-FLOW SUCTION TUBE/TOP GUN SUCTION IRRIGATOR is BYY.

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 Bio-Medical Devices, 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.

K040485MAXAIR SURGICAL HELMET SYSTEMK981888SMOKE-EVACK955149MAXI-FLOW SUCTION HANDLE/THE REEL THING TUBING REELK955150MAXI-FLOWK940156THE REEL THINGK933742TOP GUN

View all 7 devices →

Related Devices (Code: BYY)

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.

K960616VITAFLOW SUCTION/ASPIRATION TUBING SETVital Concepts, Inc.K960218CONNECTING TUBINGCustom Pack ReliabilityK955149MAXI-FLOW SUCTION HANDLE/THE REEL THING TUBING REELBio-Medical Devices, Inc.K955150MAXI-FLOWBio-Medical Devices, Inc.K922989WILTEK IRRIGAITON/ASPIRATION TUBE SETWiltek Medical, Inc.K911586GENERAL HOSPITAL TUBING CLAMP (NON-ELECTRIC)Megadyne Medical Products, 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.

↑