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FDA 510(k)

MAXIFLEX FIBER OPTIC ENERGY DELIVERY SYSTEM

K-Number: K013300 · 2002-04-16

ApplicantTechnology Delivery Systems, Inc.
Decision Date2002-04-16
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

MAXIFLEX FIBER OPTIC ENERGY DELIVERY SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Technology Delivery Systems, Inc.. It received FDA 510(k) clearance on 2002-04-16 under 510(k) number K013300. 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 MAXIFLEX FIBER OPTIC ENERGY DELIVERY SYSTEM?

MAXIFLEX FIBER OPTIC ENERGY DELIVERY SYSTEM is a medical device that received FDA 510(k) clearance on 2002-04-16. The listed applicant is Technology Delivery Systems, Inc.. The 510(k) number is K013300.

When did MAXIFLEX FIBER OPTIC ENERGY DELIVERY SYSTEM receive FDA 510(k) clearance?

MAXIFLEX FIBER OPTIC ENERGY DELIVERY SYSTEM received FDA 510(k) clearance on 2002-04-16, under 510(k) number K013300.

Who is the listed applicant for MAXIFLEX FIBER OPTIC ENERGY DELIVERY SYSTEM?

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

What is the FDA product code for MAXIFLEX FIBER OPTIC ENERGY DELIVERY SYSTEM?

The FDA product code for MAXIFLEX FIBER OPTIC ENERGY DELIVERY SYSTEM is GEX. This falls under the Gastroenterology category.

Related Clinical Trials

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Other records listing Technology Delivery Systems, 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

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