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FDA 510(k)

MODIFICATION TO TRIPTER X-1 COMPACT DUET

K-Number: K041582 · 2004-07-07

ApplicantDirex Systems Corp.
Decision Date2004-07-07
Product CodeLNS
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

MODIFICATION TO TRIPTER X-1 COMPACT DUET is the device name listed in this FDA 510(k) record. The listed applicant is Direx Systems Corp.. It received FDA 510(k) clearance on 2004-07-07 under 510(k) number K041582. 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 MODIFICATION TO TRIPTER X-1 COMPACT DUET?

MODIFICATION TO TRIPTER X-1 COMPACT DUET is a medical device that received FDA 510(k) clearance on 2004-07-07. The listed applicant is Direx Systems Corp.. The 510(k) number is K041582.

When did MODIFICATION TO TRIPTER X-1 COMPACT DUET receive FDA 510(k) clearance?

MODIFICATION TO TRIPTER X-1 COMPACT DUET received FDA 510(k) clearance on 2004-07-07, under 510(k) number K041582.

Who is the listed applicant for MODIFICATION TO TRIPTER X-1 COMPACT DUET?

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

What is the FDA product code for MODIFICATION TO TRIPTER X-1 COMPACT DUET?

The FDA product code for MODIFICATION TO TRIPTER X-1 COMPACT DUET is LNS.

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Other records listing Direx Systems Corp. 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.

K111947DUET MAGNAK102765PRONEXK072529TRACKPORTK071701TRACKLEAF-10K063482CROSSPLAN / ACCUSOFT-XL V.4.04K062147INTEGRA SL

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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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