Omnitron Gyn Applicator System

FDA 510(k) K913908 · Omnitron Intl., Inc.

Substantially Equivalent

510(k) numberK913908

Submission

Device name
Omnitron Gyn Applicator System
Applicant
Omnitron Intl., Inc.
Houston, TX, US
Received
August 30, 1991
Decision date
March 6, 1992
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
JAQ – System, Applicator, Radionuclide, Remote-Controlled
Device class
Class II (moderate risk)
Regulation
21 CFR 892.5700
Specialty
Radiology

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More from Braxx Biotech Co., Ltd.

510(k)DeviceDecision
K901615Pulmocath Intrabronchial CatheterJAQ · Traditional 11/27/1992SE
K923130IR-192 Implant -- ModificationKXK · Traditional 09/21/1992SE
K920431Omnitron Needle Applicators 18 and 21 GaugeJAQ · Traditional 05/29/1992SE
K915253IR-192 Implant, ModificationIWA · Traditional 02/27/1992SE
K911775Omnicath Implanted Catheter and DepotKXK · Traditional 05/08/1991SE
K881665Omnitron Remote Controlled Radionuclide ApplicatorJAQ · Traditional 08/11/1988SE

Questions and answers

When was Omnitron Gyn Applicator System cleared by the FDA?

Omnitron Gyn Applicator System (K913908) received a 510(k) decision of Substantially Equivalent on March 6, 1992, 189 days after the submission was received.

What is the product code of K913908?

The FDA product code is JAQ – System, Applicator, Radionuclide, Remote-Controlled, a Class II (moderate risk) device regulated under 21 CFR 892.5700.