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FDA 510(k)

OMNIPULSE/OMNIPULSE-MAX

K-Number: K962632 · 1997-01-16

ApplicantTrimedyne, Inc.
Decision Date1997-01-16
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

OMNIPULSE/OMNIPULSE-MAX is the device name listed in this FDA 510(k) record. The listed applicant is Trimedyne, Inc.. It received FDA 510(k) clearance on 1997-01-16 under 510(k) number K962632. 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 OMNIPULSE/OMNIPULSE-MAX?

OMNIPULSE/OMNIPULSE-MAX is a medical device that received FDA 510(k) clearance on 1997-01-16. The listed applicant is Trimedyne, Inc.. The 510(k) number is K962632.

When did OMNIPULSE/OMNIPULSE-MAX receive FDA 510(k) clearance?

OMNIPULSE/OMNIPULSE-MAX received FDA 510(k) clearance on 1997-01-16, under 510(k) number K962632.

Who is the listed applicant for OMNIPULSE/OMNIPULSE-MAX?

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 OMNIPULSE/OMNIPULSE-MAX?

The FDA product code for OMNIPULSE/OMNIPULSE-MAX is GEX. This falls under the Gastroenterology category.

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Other records listing Trimedyne, 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

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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