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FDA 510(k)

SpydrBlade Flex Instrument (PRD-RG1-001)

K-Number: K242774 · 2025-06-06

ApplicantCreo Medical, Ltd.
Decision Date2025-06-06
Product CodeKNS
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

SpydrBlade Flex Instrument (PRD-RG1-001) is the device name listed in this FDA 510(k) record. The listed applicant is Creo Medical, Ltd.. It received FDA 510(k) clearance on 2025-06-06 under 510(k) number K242774. 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 SpydrBlade Flex Instrument (PRD-RG1-001)?

SpydrBlade Flex Instrument (PRD-RG1-001) is a medical device that received FDA 510(k) clearance on 2025-06-06. The listed applicant is Creo Medical, Ltd.. The 510(k) number is K242774.

When did SpydrBlade Flex Instrument (PRD-RG1-001) receive FDA 510(k) clearance?

SpydrBlade Flex Instrument (PRD-RG1-001) received FDA 510(k) clearance on 2025-06-06, under 510(k) number K242774.

Who is the listed applicant for SpydrBlade Flex Instrument (PRD-RG1-001)?

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

What is the FDA product code for SpydrBlade Flex Instrument (PRD-RG1-001)?

The FDA product code for SpydrBlade Flex Instrument (PRD-RG1-001) is KNS.

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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.

K260962SphincterotomeTaewoong 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 CorporationK251104SureTome™ SW Sphincterotome with DomeTipWilson-Cook Medical

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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