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FDA 510(k)

LASER-ASSISTED DISK DECOMPRESSION ACCESSORY PACK

K-Number: K922213 · 1993-03-20

ApplicantTrimedyne, Inc.
Decision Date1993-03-20
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

LASER-ASSISTED DISK DECOMPRESSION ACCESSORY PACK is the device name listed in this FDA 510(k) record. The listed applicant is Trimedyne, Inc.. It received FDA 510(k) clearance on 1993-03-20 under 510(k) number K922213. 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 LASER-ASSISTED DISK DECOMPRESSION ACCESSORY PACK?

LASER-ASSISTED DISK DECOMPRESSION ACCESSORY PACK is a medical device that received FDA 510(k) clearance on 1993-03-20. The listed applicant is Trimedyne, Inc.. The 510(k) number is K922213.

When did LASER-ASSISTED DISK DECOMPRESSION ACCESSORY PACK receive FDA 510(k) clearance?

LASER-ASSISTED DISK DECOMPRESSION ACCESSORY PACK received FDA 510(k) clearance on 1993-03-20, under 510(k) number K922213.

Who is the listed applicant for LASER-ASSISTED DISK DECOMPRESSION ACCESSORY PACK?

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 LASER-ASSISTED DISK DECOMPRESSION ACCESSORY PACK?

The FDA product code for LASER-ASSISTED DISK DECOMPRESSION ACCESSORY PACK 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

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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