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FDA 510(k)

SCULPTURE 2.94 ER:YAG SYSTEM

K-Number: K073158 · 2008-08-27

ApplicantHoya Conbio, Inc.
Decision Date2008-08-27
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SCULPTURE 2.94 ER:YAG SYSTEM 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 2008-08-27 under 510(k) number K073158. 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 SCULPTURE 2.94 ER:YAG SYSTEM?

SCULPTURE 2.94 ER:YAG SYSTEM is a medical device that received FDA 510(k) clearance on 2008-08-27. The listed applicant is Hoya Conbio, Inc.. The 510(k) number is K073158.

When did SCULPTURE 2.94 ER:YAG SYSTEM receive FDA 510(k) clearance?

SCULPTURE 2.94 ER:YAG SYSTEM received FDA 510(k) clearance on 2008-08-27, under 510(k) number K073158.

Who is the listed applicant for SCULPTURE 2.94 ER:YAG SYSTEM?

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 SCULPTURE 2.94 ER:YAG SYSTEM?

The FDA product code for SCULPTURE 2.94 ER:YAG SYSTEM 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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