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FDA 510(k)

ULTROID HEMORRHOID MANAGEMENT SYSTEM

K-Number: K023706 · 2003-01-14

ApplicantUltroid, LLC
Decision Date2003-01-14
Product CodeKNS
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

ULTROID HEMORRHOID MANAGEMENT SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Ultroid, LLC. It received FDA 510(k) clearance on 2003-01-14 under 510(k) number K023706. The device is classified under product code KNS. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ULTROID HEMORRHOID MANAGEMENT SYSTEM?

ULTROID HEMORRHOID MANAGEMENT SYSTEM is a medical device that received FDA 510(k) clearance on 2003-01-14. The listed applicant is Ultroid, LLC. The 510(k) number is K023706.

When did ULTROID HEMORRHOID MANAGEMENT SYSTEM receive FDA 510(k) clearance?

ULTROID HEMORRHOID MANAGEMENT SYSTEM received FDA 510(k) clearance on 2003-01-14, under 510(k) number K023706.

Who is the listed applicant for ULTROID HEMORRHOID MANAGEMENT SYSTEM?

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

What is the FDA product code for ULTROID HEMORRHOID MANAGEMENT SYSTEM?

The FDA product code for ULTROID HEMORRHOID MANAGEMENT SYSTEM is KNS.

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.

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Other records listing Ultroid, LLC 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.

K030315MODIFICATION TO ULTROID HEMORRHOID MANAGEMENT SYSTEM

Related Devices (Code: KNS)

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.

K262460Rezum SystemBoston ScientificK260962SphincterotomeTaewoong Medical Co., Ltd.K252388Vanquish Water Vapor Ablation DeviceFrancis Medical, Inc.K252889Single Use 3-Lumen Needle Knife V (KD-V441M, KD-V451M)Olympus Medical Systems CorporationK250945Single Use Preloaded Sphincterotome V (Distal Wire Guided) (KD-VC600 Series); Single Use Sphincterotome V (Distal Wire Guided) (KD-VC400 Series); Single Use 3-Lumen Sphincterotome (KD-V Series); Disposable Triple Lumen Sphincterotome (KD Series)Olympus Medical Systems Corp.K250351Single Use Electrosurgical Knife (KD-612L, KD-612U); Single Use Electrosurgical Knife (KD-620UR); Single Use Electrosurgical Knife (KD-650L, KD-650U)Olympus Medical Systems Corporation

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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