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FDA 510(k)

ENDOSCOPIC LASER DELIVERY SYSTEM-LASERTX

K-Number: K023257 · 2003-03-28

ApplicantProsurg, Inc.
Decision Date2003-03-28
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ENDOSCOPIC LASER DELIVERY SYSTEM-LASERTX is the device name listed in this FDA 510(k) record. The listed applicant is Prosurg, Inc.. It received FDA 510(k) clearance on 2003-03-28 under 510(k) number K023257. 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 ENDOSCOPIC LASER DELIVERY SYSTEM-LASERTX?

ENDOSCOPIC LASER DELIVERY SYSTEM-LASERTX is a medical device that received FDA 510(k) clearance on 2003-03-28. The listed applicant is Prosurg, Inc.. The 510(k) number is K023257.

When did ENDOSCOPIC LASER DELIVERY SYSTEM-LASERTX receive FDA 510(k) clearance?

ENDOSCOPIC LASER DELIVERY SYSTEM-LASERTX received FDA 510(k) clearance on 2003-03-28, under 510(k) number K023257.

Who is the listed applicant for ENDOSCOPIC LASER DELIVERY SYSTEM-LASERTX?

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

What is the FDA product code for ENDOSCOPIC LASER DELIVERY SYSTEM-LASERTX?

The FDA product code for ENDOSCOPIC LASER DELIVERY SYSTEM-LASERTX 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.

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