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FDA 510(k)

OMNI SPHINCTEROTOME

K-Number: K052051 · 2005-08-05

ApplicantWilson-Cook Medical, Inc.
Decision Date2005-08-05
Product CodeKNS
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

OMNI SPHINCTEROTOME is the device name listed in this FDA 510(k) record. The listed applicant is Wilson-Cook Medical, Inc.. It received FDA 510(k) clearance on 2005-08-05 under 510(k) number K052051. 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 OMNI SPHINCTEROTOME?

OMNI SPHINCTEROTOME is a medical device that received FDA 510(k) clearance on 2005-08-05. The listed applicant is Wilson-Cook Medical, Inc.. The 510(k) number is K052051.

When did OMNI SPHINCTEROTOME receive FDA 510(k) clearance?

OMNI SPHINCTEROTOME received FDA 510(k) clearance on 2005-08-05, under 510(k) number K052051.

Who is the listed applicant for OMNI SPHINCTEROTOME?

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

What is the FDA product code for OMNI SPHINCTEROTOME?

The FDA product code for OMNI SPHINCTEROTOME is KNS.

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Other records listing Wilson-Cook Medical, Inc. as applicant

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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

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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