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FDA 510(k)

DORNIER MEDILAS H/2

K-Number: K984591 · 1999-03-26

ApplicantDornier Surgical Products, Inc.
Decision Date1999-03-26
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

DORNIER MEDILAS H/2 is the device name listed in this FDA 510(k) record. The listed applicant is Dornier Surgical Products, Inc.. It received FDA 510(k) clearance on 1999-03-26 under 510(k) number K984591. 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 DORNIER MEDILAS H/2?

DORNIER MEDILAS H/2 is a medical device that received FDA 510(k) clearance on 1999-03-26. The listed applicant is Dornier Surgical Products, Inc.. The 510(k) number is K984591.

When did DORNIER MEDILAS H/2 receive FDA 510(k) clearance?

DORNIER MEDILAS H/2 received FDA 510(k) clearance on 1999-03-26, under 510(k) number K984591.

Who is the listed applicant for DORNIER MEDILAS H/2?

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

What is the FDA product code for DORNIER MEDILAS H/2?

The FDA product code for DORNIER MEDILAS H/2 is GEX. This falls under the Gastroenterology category.

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Other records listing Dornier Surgical Products, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K003993DORNIER MEDILAS D SKINPULSE LASER SYSTEM (SKINPULSE)K000072DORNIER MEDILAS D SKINPULSEK001243DORNIER MEDILAS HK993146DORNIER SCANNER HANDPIECEK991183DORNIER LASERTRODE FIBERK982629DORNIER MEDILAS D

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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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