UROLOGIC — FDA 510(k) K011311

Device Summary

UROLOGIC is the device name listed in this FDA 510(k) record. The listed applicant is Pck Electronic Industry and Trade Co, Ltd.. It received FDA 510(k) clearance on 2001-07-10 under 510(k) number K011311. The device is classified under product code OWB. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the UROLOGIC?

UROLOGIC is a medical device that received FDA 510(k) clearance on 2001-07-10. The listed applicant is Pck Electronic Industry and Trade Co, Ltd.. The 510(k) number is K011311.

When did UROLOGIC receive FDA 510(k) clearance?

UROLOGIC received FDA 510(k) clearance on 2001-07-10, under 510(k) number K011311.

Who is the listed applicant for UROLOGIC?

The FDA 510(k) record lists Pck Electronic Industry and Trade Co, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for UROLOGIC?

The FDA product code for UROLOGIC is OWB.

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Related PubMed Literature

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PMID: 41886403Urologic Device Innovation and Trends: An Analysis of Food and Drug Administration Approvals From 1990 to 2023.Urology practice ()PMID: 38269047Characteristics and use of patient-reported outcomes of clinical trials for high-risk neurological medical devices that received FDA premarket approval from 2001 to 2022.Contemporary clinical trials communications ()PMID: 34087794US FDA best practices for initiating early feasibility studies for neurological devices in the United States.Journal of neurosurgery ()PMID: 30596410Neurological Devices; Reclassification of Electroconvulsive Therapy Devices; Effective Date of Requirement for Premarket Approval for Electroconvulsive Therapy Devices for Certain Specified Intended Uses. Final order.Federal register ()

Other records listing Pck Electronic Industry and Trade Co, Ltd. 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.

K061350LITHODIAMOND ULTRA K053279UROVANTAGE K011106STONELITH, MODEL V5

Related Devices (Code: OWB)

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Official Source

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