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FDA 510(k)

DORNIER LASERTRODE FIBER

K-Number: K991183 · 1999-06-09

ApplicantDornier Surgical Products, Inc.
Decision Date1999-06-09
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

DORNIER LASERTRODE FIBER 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 1999-06-09 under 510(k) number K991183. 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 LASERTRODE FIBER?

DORNIER LASERTRODE FIBER is a medical device that received FDA 510(k) clearance on 1999-06-09. The listed applicant is Dornier Surgical Products, Inc.. The 510(k) number is K991183.

When did DORNIER LASERTRODE FIBER receive FDA 510(k) clearance?

DORNIER LASERTRODE FIBER received FDA 510(k) clearance on 1999-06-09, under 510(k) number K991183.

Who is the listed applicant for DORNIER LASERTRODE FIBER?

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 LASERTRODE FIBER?

The FDA product code for DORNIER LASERTRODE FIBER 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 HANDPIECEK984591DORNIER MEDILAS H/2K982629DORNIER 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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