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FDA 510(k)

DORNIER SCANNER HANDPIECE

K-Number: K993146 · 1999-11-08

ApplicantDornier Surgical Products, Inc.
Decision Date1999-11-08
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

DORNIER SCANNER HANDPIECE 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 1999-11-08 under 510(k) number K993146. 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 SCANNER HANDPIECE?

DORNIER SCANNER HANDPIECE is a medical device that received FDA 510(k) clearance on 1999-11-08. The listed applicant is Dornier Surgical Products, Inc.. The 510(k) number is K993146.

When did DORNIER SCANNER HANDPIECE receive FDA 510(k) clearance?

DORNIER SCANNER HANDPIECE received FDA 510(k) clearance on 1999-11-08, under 510(k) number K993146.

Who is the listed applicant for DORNIER SCANNER HANDPIECE?

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 SCANNER HANDPIECE?

The FDA product code for DORNIER SCANNER HANDPIECE 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.

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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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