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FDA 510(k)

MEDILAS 4060N FIBERTOM(R) SURGICAL LASER

K-Number: K904155 · 1990-11-21

ApplicantDornier Medtech America, Inc.
Decision Date1990-11-21
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

MEDILAS 4060N FIBERTOM(R) SURGICAL LASER is the device name listed in this FDA 510(k) record. The listed applicant is Dornier Medtech America, Inc.. It received FDA 510(k) clearance on 1990-11-21 under 510(k) number K904155. 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 MEDILAS 4060N FIBERTOM(R) SURGICAL LASER?

MEDILAS 4060N FIBERTOM(R) SURGICAL LASER is a medical device that received FDA 510(k) clearance on 1990-11-21. The listed applicant is Dornier Medtech America, Inc.. The 510(k) number is K904155.

When did MEDILAS 4060N FIBERTOM(R) SURGICAL LASER receive FDA 510(k) clearance?

MEDILAS 4060N FIBERTOM(R) SURGICAL LASER received FDA 510(k) clearance on 1990-11-21, under 510(k) number K904155.

Who is the listed applicant for MEDILAS 4060N FIBERTOM(R) SURGICAL LASER?

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

What is the FDA product code for MEDILAS 4060N FIBERTOM(R) SURGICAL LASER?

The FDA product code for MEDILAS 4060N FIBERTOM(R) SURGICAL LASER 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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