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FDA 510(k)

SURGICAL LIGHTSTIC, MODELS, 180 L, AND 180 C

K-Number: K993834 · 2000-02-04

ApplicantCardiofocus, Inc.
Decision Date2000-02-04
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SURGICAL LIGHTSTIC, MODELS, 180 L, AND 180 C is the device name listed in this FDA 510(k) record. The listed applicant is Cardiofocus, Inc.. It received FDA 510(k) clearance on 2000-02-04 under 510(k) number K993834. 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 SURGICAL LIGHTSTIC, MODELS, 180 L, AND 180 C?

SURGICAL LIGHTSTIC, MODELS, 180 L, AND 180 C is a medical device that received FDA 510(k) clearance on 2000-02-04. The listed applicant is Cardiofocus, Inc.. The 510(k) number is K993834.

When did SURGICAL LIGHTSTIC, MODELS, 180 L, AND 180 C receive FDA 510(k) clearance?

SURGICAL LIGHTSTIC, MODELS, 180 L, AND 180 C received FDA 510(k) clearance on 2000-02-04, under 510(k) number K993834.

Who is the listed applicant for SURGICAL LIGHTSTIC, MODELS, 180 L, AND 180 C?

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

What is the FDA product code for SURGICAL LIGHTSTIC, MODELS, 180 L, AND 180 C?

The FDA product code for SURGICAL LIGHTSTIC, MODELS, 180 L, AND 180 C is GEX. This falls under the Gastroenterology category.

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Other records listing Cardiofocus, 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

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