Omnitron Needle Applicators 18 and 21 Gauge
FDA 510(k) K920431 · Omnitron Intl., Inc.
510(k) numberK920431
Submission
- Device name
- Omnitron Needle Applicators 18 and 21 Gauge
- Applicant
- Omnitron Intl., Inc.
Houston, TX, US - Received
- February 3, 1992
- Decision date
- May 29, 1992
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Other 510(k)s with product code JAQ
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| K262383 | LumenCare AzureJAQ · Special | Nucletron B.V. | 07/24/2026SE |
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| K251037 | Rectal ApplicatorJAQ · Traditional | Nucletron B.V. | 12/19/2025SE |
| K252884 | Guided Aarhus Applicator SetJAQ · Traditional | Varian Medical Systems | 11/19/2025SE |
| K250299 | CT/ MR Tandem and Ovoid SetJAQ · Traditional | Varian Medical Systems, Inc. | 05/09/2025SE |
| K250289 | Intracavitary/Interstitial SystemJAQ · Traditional | Varian Medical Systems | 04/25/2025SE |
| K243939 | Titanium Flexible Geometry FSD Applicator Set (GM11013400)JAQ · Traditional | Varian Medical Systems, Inc. | 03/03/2025SE |
| K241764 | Mould Probe MR SafeJAQ · Traditional | Varian Medical Systems, Inc. | 01/10/2025SE |
| K242961 | Intraluminal Applicator SetJAQ · Traditional | Varian Medical Systems | 11/26/2024SE |
| K243045 | BRAXX Esophageal Brachytherapy Applicator (Model: BKMI2001, BKMI2002)JAQ · Special | Braxx Biotech Co., Ltd. | 11/19/2024SE |
More from Braxx Biotech Co., Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K901615 | Pulmocath Intrabronchial CatheterJAQ · Traditional | 11/27/1992SE |
| K923130 | IR-192 Implant -- ModificationKXK · Traditional | 09/21/1992SE |
| K913908 | Omnitron Gyn Applicator SystemJAQ · Traditional | 03/06/1992SE |
| K915253 | IR-192 Implant, ModificationIWA · Traditional | 02/27/1992SE |
| K911775 | Omnicath Implanted Catheter and DepotKXK · Traditional | 05/08/1991SE |
| K881665 | Omnitron Remote Controlled Radionuclide ApplicatorJAQ · Traditional | 08/11/1988SE |
Questions and answers
When was Omnitron Needle Applicators 18 and 21 Gauge cleared by the FDA?
Omnitron Needle Applicators 18 and 21 Gauge (K920431) received a 510(k) decision of Substantially Equivalent on May 29, 1992, 116 days after the submission was received.
What is the product code of K920431?
The FDA product code is JAQ – System, Applicator, Radionuclide, Remote-Controlled, a Class II (moderate risk) device regulated under 21 CFR 892.5700.