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FDA 510(k)

XTEND

K-Number: K980752 · 1998-05-06

ApplicantWalling Medical Equipment Co.
Decision Date1998-05-06
Product CodeLKY
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

XTEND is the device name listed in this FDA 510(k) record. The listed applicant is Walling Medical Equipment Co.. It received FDA 510(k) clearance on 1998-05-06 under 510(k) number K980752. The device is classified under product code LKY. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the XTEND?

XTEND is a medical device that received FDA 510(k) clearance on 1998-05-06. The listed applicant is Walling Medical Equipment Co.. The 510(k) number is K980752.

When did XTEND receive FDA 510(k) clearance?

XTEND received FDA 510(k) clearance on 1998-05-06, under 510(k) number K980752.

Who is the listed applicant for XTEND?

The FDA 510(k) record lists Walling Medical Equipment Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for XTEND?

The FDA product code for XTEND is LKY.

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

Related PubMed Literature

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.

PMID: 35968225The oversight of autonomous artificial intelligence: lessons from nurse practitioners as physician extenders.Journal of law and the biosciences ()

Other records listing Walling Medical Equipment Co. 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.

K980567CHARGER (ED)K971768RELIANT CHARGERK940995RELIANT CONSTRICTION RING

Related Devices (Code: LKY)

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.

K041573NANMA VACUUM PUMP PROXZEK MODEL 2M9498SNanma Mfg Co., Ltd.K032776VACURECT VACUUM CONSTRICTION DEVICEVacurect Manufacturing (Pty) , Ltd.K030119NANMA ADJUSTABLE CONSTRICTION RINGNanma Mfg Co., Ltd.K030913NANMA VACUUM PUMPNanma Mfg Co., Ltd.K013113MODIFICATION TO NANMA VACUUM PUMPNanma Mfg Co., Ltd.K013051NANMA ADJUSTABLE CONSTRICTION RINGNanma Mfg Co., Ltd.

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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