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FDA 510(k)

LEONARD TUBE

K-Number: K892334 · 1989-05-31

ApplicantSurgidyne, Inc.
Decision Date1989-05-31
Product CodeKDH
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

LEONARD TUBE is the device name listed in this FDA 510(k) record. The listed applicant is Surgidyne, Inc.. It received FDA 510(k) clearance on 1989-05-31 under 510(k) number K892334. The device is classified under product code KDH. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LEONARD TUBE?

LEONARD TUBE is a medical device that received FDA 510(k) clearance on 1989-05-31. The listed applicant is Surgidyne, Inc.. The 510(k) number is K892334.

When did LEONARD TUBE receive FDA 510(k) clearance?

LEONARD TUBE received FDA 510(k) clearance on 1989-05-31, under 510(k) number K892334.

Who is the listed applicant for LEONARD TUBE?

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

What is the FDA product code for LEONARD TUBE?

The FDA product code for LEONARD TUBE is KDH.

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 Surgidyne, 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.

K883582VARIDYNE MODEL 250 SUCTION DRAINAGE SYSTEMK864822VARIDYNE 550, MODELS 12E,12M,24E & 24M SUCTION SYSK860030SURGIDYNE VARIDYNE, MODEL 140-2I & MODEL 140-2IDK852180SURGIDYNES VARIDYNE 350-2I & 350-2C CORDLESS ELEC.K850634SURGIDYNE SURGIFLO C.W.S. DRAIN PRODUCTS

Related Devices (Code: KDH)

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.

K983624GILTECH PLUS CONNECTING TUBE SETGiltech Plus, Inc.K981286SUPERFLOW IRRIGATION AND ASPIRATION TUBING SETSArmm, Inc.K971259COMBIPORT FLUID LAVAGE DEVICEB.Braun Medical, Inc.K962850TUM-E-VACEthox Corp.K951533EASI-LAV PEDIATRIC / ADULT GASTRIC LAVAGE KITBallard Medical ProductsK923497FLUSHING IRRIGATION SETOrion Life Systems, 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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