FDA 510(k)

LASER ENDOSCOPIC DECOMPRESSION KIT, MODEL 1100, AND PERCUTANEOUS DISCECTOMY KIT, MODEL 1120

K-Number: K040424 · 2004-05-11

Decision Date2004-05-11

Product CodeGEX

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

LASER ENDOSCOPIC DECOMPRESSION KIT, MODEL 1100, AND PERCUTANEOUS DISCECTOMY KIT, MODEL 1120 is the device name listed in this FDA 510(k) record. The listed applicant is Clarus Medical, LLC. It received FDA 510(k) clearance on 2004-05-11 under 510(k) number K040424. The device is classified under product code GEX. It was reviewed by the SU advisory panel. Product code GEX falls under the category of Gastroenterology, which includes gastrointestinal diagnostic and therapeutic devices. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LASER ENDOSCOPIC DECOMPRESSION KIT, MODEL 1100, AND PERCUTANEOUS DISCECTOMY KIT, MODEL 1120?

LASER ENDOSCOPIC DECOMPRESSION KIT, MODEL 1100, AND PERCUTANEOUS DISCECTOMY KIT, MODEL 1120 is a medical device that received FDA 510(k) clearance on 2004-05-11. The listed applicant is Clarus Medical, LLC. The 510(k) number is K040424.

When did LASER ENDOSCOPIC DECOMPRESSION KIT, MODEL 1100, AND PERCUTANEOUS DISCECTOMY KIT, MODEL 1120 receive FDA 510(k) clearance?

LASER ENDOSCOPIC DECOMPRESSION KIT, MODEL 1100, AND PERCUTANEOUS DISCECTOMY KIT, MODEL 1120 received FDA 510(k) clearance on 2004-05-11, under 510(k) number K040424.

Who is the listed applicant for LASER ENDOSCOPIC DECOMPRESSION KIT, MODEL 1100, AND PERCUTANEOUS DISCECTOMY KIT, MODEL 1120?

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

What is the FDA product code for LASER ENDOSCOPIC DECOMPRESSION KIT, MODEL 1100, AND PERCUTANEOUS DISCECTOMY KIT, MODEL 1120?

The FDA product code for LASER ENDOSCOPIC DECOMPRESSION KIT, MODEL 1100, AND PERCUTANEOUS DISCECTOMY KIT, MODEL 1120 is GEX. This falls under the Gastroenterology category.

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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.