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FDA 510(k)

OAB Delivery Catheter

K-Number: K253422 · 2026-10-02

ApplicantCognition Medical Corp.
Decision Date2026-10-02
Product CodeQJP
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

OAB Delivery Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Cognition Medical Corp.. It received FDA 510(k) clearance on 2026-10-02 under 510(k) number K253422. The device is classified under product code QJP. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OAB Delivery Catheter?

OAB Delivery Catheter is a medical device that received FDA 510(k) clearance on 2026-10-02. The listed applicant is Cognition Medical Corp.. The 510(k) number is K253422.

When did OAB Delivery Catheter receive FDA 510(k) clearance?

OAB Delivery Catheter received FDA 510(k) clearance on 2026-10-02, under 510(k) number K253422.

Who is the listed applicant for OAB Delivery Catheter?

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

What is the FDA product code for OAB Delivery Catheter?

The FDA product code for OAB Delivery Catheter is QJP.

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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Related Devices (Code: QJP)

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.

K260220Route 92 Medical Full Length 046 Access SystemRoute 92 Medical, Inc.K26227770 NeuGlide CatheterPiraeus Medical, Inc.K261176Zoom 4S CatheterImperative Care, Inc.K254071p17 XR MicrocatheterWallaby MedicalK260199SLIM MicrocatheterBalt USA, LLCK253901Millipede88 Access CatheterPerfuze, 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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