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FDA 510(k)

INNOVATECH ILLUMINATING LASER PROBE, MODEL 420-30

K-Number: K032704 · 2003-10-24

ApplicantInnovatech Surgical, Inc.
Decision Date2003-10-24
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

INNOVATECH ILLUMINATING LASER PROBE, MODEL 420-30 is the device name listed in this FDA 510(k) record. The listed applicant is Innovatech Surgical, Inc.. It received FDA 510(k) clearance on 2003-10-24 under 510(k) number K032704. 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 INNOVATECH ILLUMINATING LASER PROBE, MODEL 420-30?

INNOVATECH ILLUMINATING LASER PROBE, MODEL 420-30 is a medical device that received FDA 510(k) clearance on 2003-10-24. The listed applicant is Innovatech Surgical, Inc.. The 510(k) number is K032704.

When did INNOVATECH ILLUMINATING LASER PROBE, MODEL 420-30 receive FDA 510(k) clearance?

INNOVATECH ILLUMINATING LASER PROBE, MODEL 420-30 received FDA 510(k) clearance on 2003-10-24, under 510(k) number K032704.

Who is the listed applicant for INNOVATECH ILLUMINATING LASER PROBE, MODEL 420-30?

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

What is the FDA product code for INNOVATECH ILLUMINATING LASER PROBE, MODEL 420-30?

The FDA product code for INNOVATECH ILLUMINATING LASER PROBE, MODEL 420-30 is GEX. This falls under the Gastroenterology category.

Related Clinical Trials

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Other records listing Innovatech Surgical, 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.

K032703INNOVATECH STRAIGHT LASER PROBE, MODEL 420-10

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Official Source

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