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FDA 510(k)

LITHODIAMOND ULTRA

K-Number: K061350 · 2006-12-22

ApplicantPck Electronic Industry & Trade Co., Ltd.
Decision Date2006-12-22
Product CodeLNS
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

LITHODIAMOND ULTRA is the device name listed in this FDA 510(k) record. The listed applicant is Pck Electronic Industry & Trade Co., Ltd.. It received FDA 510(k) clearance on 2006-12-22 under 510(k) number K061350. The device is classified under product code LNS. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LITHODIAMOND ULTRA?

LITHODIAMOND ULTRA is a medical device that received FDA 510(k) clearance on 2006-12-22. The listed applicant is Pck Electronic Industry & Trade Co., Ltd.. The 510(k) number is K061350.

When did LITHODIAMOND ULTRA receive FDA 510(k) clearance?

LITHODIAMOND ULTRA received FDA 510(k) clearance on 2006-12-22, under 510(k) number K061350.

Who is the listed applicant for LITHODIAMOND ULTRA?

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

What is the FDA product code for LITHODIAMOND ULTRA?

The FDA product code for LITHODIAMOND ULTRA is LNS.

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 Pck Electronic Industry & 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.

K053279UROVANTAGEK011106STONELITH, MODEL V5K011311UROLOGIC

Related Devices (Code: LNS)

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.

K261086Break WaveSonomotion, Inc.K252913Break WaveSonomotion, Inc.K242922Extracorporeal Shock Wave Lithotripter (U200)Shenzhen Wikkon Precision Technologies Co., Ltd.K221903Delta III ProDornier Medtech America, Inc.K213772LM-9300 Plus LithotripterLite-Med, Inc.K201001Modulith SLX-F2Karl Storz Endoscopy America

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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