CT F/S/D Compatible Applicators (Fletcher), HDR Compatible Tandem and Ovoid Applicators (Henschke), HDR CT Compatible Split Ring Applicator, Segmented Vaginal Applicator, HDR Miami Applicator HDR Brachytherapy Applicator, 2/3 Endometrial Applicator Sets, CT HDR Ring & Tandem Applicator with Rectal Retractor
FDA 510(k) K200221 · Mick Radio-Nuclear Instruments, Inc.
510(k) numberK200221
Submission
- Device name
- CT F/S/D Compatible Applicators (Fletcher), HDR Compatible Tandem and Ovoid Applicators (Henschke), HDR CT Compatible Split Ring Applicator, Segmented Vaginal Applicator, HDR Miami Applicator HDR Brachytherapy Applicator, 2/3 Endometrial Applicator Sets, CT HDR Ring & Tandem Applicator with Rectal Retractor
- Applicant
- Mick Radio-Nuclear Instruments, Inc.
Mt. Vernon, NY, US - Received
- January 29, 2020
- Decision date
- February 28, 2020
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Other 510(k)s with product code JAQ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K262383 | LumenCare AzureJAQ · Special | Nucletron B.V. | 07/24/2026SE |
| K252717 | MAASTRO Rectal Applicator SetJAQ · Traditional | Varian Medical Systems | 05/20/2026SE |
| 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 |
|---|---|---|
| K230155 | Mick Valencia Applicator SetJAQ · Traditional | 08/30/2023SE |
| K150979 | CT/MR Compatible M.A.C. Interstitial GYN TemplateJAQ · Traditional | 05/31/2016SE |
| K142597 | Vienna SystemJAQ · Traditional | 02/19/2015SE |
| K122840 | CT HDR Tandem/Ring Applicator with Rectal Retractor Model 0407JAQ · Traditional | 12/14/2012SE |
| K063382 | HDR CT Compatible Split Ring ApplicatorJAQ · Traditional | 12/26/2006SE |
| K063381 | CT Compatible F/S/D ApplicatorsJAQ · Traditional | 12/22/2006SE |
| K052351 | HDR Iort Shielded ApplicatorJAQ · Traditional | 10/17/2005SE |
| K051423 | Mick HDR Interstitial Implant AccessoriesJAQ · Traditional | 07/01/2005SE |
| K040704 | Modification to Henschke HDR Cervix Applicator and Hilaris/Nori HDR Cervix ApplicatorJAQ · Traditional | 06/18/2004SE |
| K033828 | CT Compatible Intrauterine Sleeves, Cat #0311, 9406JAQ · Traditional | 02/02/2004SE |
Questions and answers
When was CT F/S/D Compatible Applicators (Fletcher), HDR Compatible Tandem and Ovoid Applicators (Henschke), HDR CT Compatible Split Ring Applicator, Segmented Vaginal Applicator, HDR Miami Applicator HDR Brachytherapy Applicator, 2/3 Endometrial Applicator Sets, CT HDR Ring & Tandem Applicator with Rectal Retractor cleared by the FDA?
CT F/S/D Compatible Applicators (Fletcher), HDR Compatible Tandem and Ovoid Applicators (Henschke), HDR CT Compatible Split Ring Applicator, Segmented Vaginal Applicator, HDR Miami Applicator HDR Brachytherapy Applicator, 2/3 Endometrial Applicator Sets, CT HDR Ring & Tandem Applicator with Rectal Retractor (K200221) received a 510(k) decision of Substantially Equivalent on February 28, 2020, 30 days after the submission was received.
What is the product code of K200221?
The FDA product code is JAQ – System, Applicator, Radionuclide, Remote-Controlled, a Class II (moderate risk) device regulated under 21 CFR 892.5700.