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FDA 510(k)

DUAL HOOK FIBEROPTIC DELIVERY SYSTEM

K-Number: K970069 · 1998-07-17

ApplicantIhd, Inc.
Decision Date1998-07-17
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

DUAL HOOK FIBEROPTIC DELIVERY SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Ihd, Inc.. It received FDA 510(k) clearance on 1998-07-17 under 510(k) number K970069. 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 DUAL HOOK FIBEROPTIC DELIVERY SYSTEM?

DUAL HOOK FIBEROPTIC DELIVERY SYSTEM is a medical device that received FDA 510(k) clearance on 1998-07-17. The listed applicant is Ihd, Inc.. The 510(k) number is K970069.

When did DUAL HOOK FIBEROPTIC DELIVERY SYSTEM receive FDA 510(k) clearance?

DUAL HOOK FIBEROPTIC DELIVERY SYSTEM received FDA 510(k) clearance on 1998-07-17, under 510(k) number K970069.

Who is the listed applicant for DUAL HOOK FIBEROPTIC DELIVERY SYSTEM?

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

What is the FDA product code for DUAL HOOK FIBEROPTIC DELIVERY SYSTEM?

The FDA product code for DUAL HOOK FIBEROPTIC DELIVERY SYSTEM is GEX. This falls under the Gastroenterology category.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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