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FDA 510(k)

MEDLITE C SERIES COMPRESSION TOOL AND HANDPIECE ATTACHMENT ACCESSORY, MODEL 659-0523

K-Number: K060977 · 2006-05-24

ApplicantHoya Conbio, Inc.
Decision Date2006-05-24
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

MEDLITE C SERIES COMPRESSION TOOL AND HANDPIECE ATTACHMENT ACCESSORY, MODEL 659-0523 is the device name listed in this FDA 510(k) record. The listed applicant is Hoya Conbio, Inc.. It received FDA 510(k) clearance on 2006-05-24 under 510(k) number K060977. 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 MEDLITE C SERIES COMPRESSION TOOL AND HANDPIECE ATTACHMENT ACCESSORY, MODEL 659-0523?

MEDLITE C SERIES COMPRESSION TOOL AND HANDPIECE ATTACHMENT ACCESSORY, MODEL 659-0523 is a medical device that received FDA 510(k) clearance on 2006-05-24. The listed applicant is Hoya Conbio, Inc.. The 510(k) number is K060977.

When did MEDLITE C SERIES COMPRESSION TOOL AND HANDPIECE ATTACHMENT ACCESSORY, MODEL 659-0523 receive FDA 510(k) clearance?

MEDLITE C SERIES COMPRESSION TOOL AND HANDPIECE ATTACHMENT ACCESSORY, MODEL 659-0523 received FDA 510(k) clearance on 2006-05-24, under 510(k) number K060977.

Who is the listed applicant for MEDLITE C SERIES COMPRESSION TOOL AND HANDPIECE ATTACHMENT ACCESSORY, MODEL 659-0523?

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

What is the FDA product code for MEDLITE C SERIES COMPRESSION TOOL AND HANDPIECE ATTACHMENT ACCESSORY, MODEL 659-0523?

The FDA product code for MEDLITE C SERIES COMPRESSION TOOL AND HANDPIECE ATTACHMENT ACCESSORY, MODEL 659-0523 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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