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FDA 510(k)

DISPOSABLE SPINAL INTRODUCER SHEATH

K-Number: K941419 · 1994-06-21

ApplicantTrimedyne, Inc.
Decision Date1994-06-21
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

DISPOSABLE SPINAL INTRODUCER 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 1994-06-21 under 510(k) number K941419. 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 DISPOSABLE SPINAL INTRODUCER SHEATH?

DISPOSABLE SPINAL INTRODUCER SHEATH is a medical device that received FDA 510(k) clearance on 1994-06-21. The listed applicant is Trimedyne, Inc.. The 510(k) number is K941419.

When did DISPOSABLE SPINAL INTRODUCER SHEATH receive FDA 510(k) clearance?

DISPOSABLE SPINAL INTRODUCER SHEATH received FDA 510(k) clearance on 1994-06-21, under 510(k) number K941419.

Who is the listed applicant for DISPOSABLE SPINAL INTRODUCER 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 DISPOSABLE SPINAL INTRODUCER SHEATH?

The FDA product code for DISPOSABLE SPINAL INTRODUCER SHEATH is GEX. This falls under the Gastroenterology category.

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Other records listing Trimedyne, Inc. as applicant

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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