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FDA 510(k)

ODYSSEY HO:YAG SURGICAL LASER SYSTEMS & ACCESSORIES

K-Number: K951910 · 1995-12-27

ApplicantXintec Corporation
Decision Date1995-12-27
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ODYSSEY HO:YAG SURGICAL LASER SYSTEMS & ACCESSORIES is the device name listed in this FDA 510(k) record. The listed applicant is Xintec Corporation. It received FDA 510(k) clearance on 1995-12-27 under 510(k) number K951910. 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 ODYSSEY HO:YAG SURGICAL LASER SYSTEMS & ACCESSORIES?

ODYSSEY HO:YAG SURGICAL LASER SYSTEMS & ACCESSORIES is a medical device that received FDA 510(k) clearance on 1995-12-27. The listed applicant is Xintec Corporation. The 510(k) number is K951910.

When did ODYSSEY HO:YAG SURGICAL LASER SYSTEMS & ACCESSORIES receive FDA 510(k) clearance?

ODYSSEY HO:YAG SURGICAL LASER SYSTEMS & ACCESSORIES received FDA 510(k) clearance on 1995-12-27, under 510(k) number K951910.

Who is the listed applicant for ODYSSEY HO:YAG SURGICAL LASER SYSTEMS & ACCESSORIES?

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 ODYSSEY HO:YAG SURGICAL LASER SYSTEMS & ACCESSORIES?

The FDA product code for ODYSSEY HO:YAG SURGICAL LASER SYSTEMS & ACCESSORIES 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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