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FDA 510(k)

RESPOSABLE OMNI TIP(TM) SWITCHABLE TIPS (MULTIPLE)

K-Number: K964585 · 1997-04-17

ApplicantTrimedyne, Inc.
Decision Date1997-04-17
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

RESPOSABLE OMNI TIP(TM) SWITCHABLE TIPS (MULTIPLE) is the device name listed in this FDA 510(k) record. The listed applicant is Trimedyne, Inc.. It received FDA 510(k) clearance on 1997-04-17 under 510(k) number K964585. 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 RESPOSABLE OMNI TIP(TM) SWITCHABLE TIPS (MULTIPLE)?

RESPOSABLE OMNI TIP(TM) SWITCHABLE TIPS (MULTIPLE) is a medical device that received FDA 510(k) clearance on 1997-04-17. The listed applicant is Trimedyne, Inc.. The 510(k) number is K964585.

When did RESPOSABLE OMNI TIP(TM) SWITCHABLE TIPS (MULTIPLE) receive FDA 510(k) clearance?

RESPOSABLE OMNI TIP(TM) SWITCHABLE TIPS (MULTIPLE) received FDA 510(k) clearance on 1997-04-17, under 510(k) number K964585.

Who is the listed applicant for RESPOSABLE OMNI TIP(TM) SWITCHABLE TIPS (MULTIPLE)?

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 RESPOSABLE OMNI TIP(TM) SWITCHABLE TIPS (MULTIPLE)?

The FDA product code for RESPOSABLE OMNI TIP(TM) SWITCHABLE TIPS (MULTIPLE) 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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