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FDA 510(k)

PROTEGE II ER: YAG LASER SYSTEM AND ACCESSOIES (UPGRADE)

K-Number: K981627 · 1998-07-31

ApplicantXintec Corporation
Decision Date1998-07-31
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

PROTEGE II ER: YAG LASER SYSTEM AND ACCESSOIES (UPGRADE) is the device name listed in this FDA 510(k) record. The listed applicant is Xintec Corporation. It received FDA 510(k) clearance on 1998-07-31 under 510(k) number K981627. 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 PROTEGE II ER: YAG LASER SYSTEM AND ACCESSOIES (UPGRADE)?

PROTEGE II ER: YAG LASER SYSTEM AND ACCESSOIES (UPGRADE) is a medical device that received FDA 510(k) clearance on 1998-07-31. The listed applicant is Xintec Corporation. The 510(k) number is K981627.

When did PROTEGE II ER: YAG LASER SYSTEM AND ACCESSOIES (UPGRADE) receive FDA 510(k) clearance?

PROTEGE II ER: YAG LASER SYSTEM AND ACCESSOIES (UPGRADE) received FDA 510(k) clearance on 1998-07-31, under 510(k) number K981627.

Who is the listed applicant for PROTEGE II ER: YAG LASER SYSTEM AND ACCESSOIES (UPGRADE)?

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

What is the FDA product code for PROTEGE II ER: YAG LASER SYSTEM AND ACCESSOIES (UPGRADE)?

The FDA product code for PROTEGE II ER: YAG LASER SYSTEM AND ACCESSOIES (UPGRADE) 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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