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FDA 510(k)

NOVATIP FAMILY OF LASER HANDPIECE TIPS

K-Number: K971539 · 1997-06-03

ApplicantXanova Corp.
Decision Date1997-06-03
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

NOVATIP FAMILY OF LASER HANDPIECE TIPS is the device name listed in this FDA 510(k) record. The listed applicant is Xanova Corp.. It received FDA 510(k) clearance on 1997-06-03 under 510(k) number K971539. 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 NOVATIP FAMILY OF LASER HANDPIECE TIPS?

NOVATIP FAMILY OF LASER HANDPIECE TIPS is a medical device that received FDA 510(k) clearance on 1997-06-03. The listed applicant is Xanova Corp.. The 510(k) number is K971539.

When did NOVATIP FAMILY OF LASER HANDPIECE TIPS receive FDA 510(k) clearance?

NOVATIP FAMILY OF LASER HANDPIECE TIPS received FDA 510(k) clearance on 1997-06-03, under 510(k) number K971539.

Who is the listed applicant for NOVATIP FAMILY OF LASER HANDPIECE TIPS?

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

What is the FDA product code for NOVATIP FAMILY OF LASER HANDPIECE TIPS?

The FDA product code for NOVATIP FAMILY OF LASER HANDPIECE TIPS is GEX. This falls under the Gastroenterology category.

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Official Source

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