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FDA 510(k)

TRIMEDYNE SIDE FIRING NEEDLE WITH VENT SHEATH

K-Number: K022655 · 2002-11-07

ApplicantTrimedyne, Inc.
Decision Date2002-11-07
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

TRIMEDYNE SIDE FIRING NEEDLE WITH VENT SHEATH is the device name listed in this FDA 510(k) record. The listed applicant is Trimedyne, Inc.. It received FDA 510(k) clearance on 2002-11-07 under 510(k) number K022655. 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 TRIMEDYNE SIDE FIRING NEEDLE WITH VENT SHEATH?

TRIMEDYNE SIDE FIRING NEEDLE WITH VENT SHEATH is a medical device that received FDA 510(k) clearance on 2002-11-07. The listed applicant is Trimedyne, Inc.. The 510(k) number is K022655.

When did TRIMEDYNE SIDE FIRING NEEDLE WITH VENT SHEATH receive FDA 510(k) clearance?

TRIMEDYNE SIDE FIRING NEEDLE WITH VENT SHEATH received FDA 510(k) clearance on 2002-11-07, under 510(k) number K022655.

Who is the listed applicant for TRIMEDYNE SIDE FIRING NEEDLE WITH VENT SHEATH?

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

What is the FDA product code for TRIMEDYNE SIDE FIRING NEEDLE WITH VENT SHEATH?

The FDA product code for TRIMEDYNE SIDE FIRING NEEDLE WITH VENT SHEATH 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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