Hilaris-Nori Endometrial Applicator
FDA 510(k) K871216 · Mick Radio-Nuclear Instruments, Inc.
510(k) numberK871216
Submission
- Device name
- Hilaris-Nori Endometrial Applicator
- Applicant
- Mick Radio-Nuclear Instruments, Inc.
Bronx, NY, US - Received
- March 26, 1987
- Decision date
- July 21, 1987
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Other 510(k)s with product code IWJ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K010166 | Imagyn Isosleeve / Isostar Needle SystemIWJ · Traditional | Imagyn Medical Technologies, Inc. | 12/03/2001SE |
| K980997 | PGK Device (Modified)IWJ · Traditional | Pgk, Inc. | 09/28/1998SE |
| K972554 | Reganes Radionuclide Seed MagazineIWJ · Traditional | Avid N.I.T., Inc. | 02/17/1998SE |
| K973037 | N.I.T., Inc. Radionuclide Seed Applicator, Model SA-1000IWJ · Traditional | Avid N.I.T., Inc. | 01/27/1998SE |
| K974118 | Worldwide Medical Technologies Seed Implant Needle SetIWJ · Traditional | Worldwide Medical Technologies, LLC | 01/23/1998SE |
| K973786 | Northwest Radiation Therapy Products, Precision Stepper and GuideIWJ · Traditional | Nw Radiation Therapy Products | 01/02/1998SE |
| K973638 | N.I.T., Inc. Needle Guiding TemplateIWJ · Traditional | Avid N.I.T., Inc. | 12/23/1997SE |
| K973184 | Prostate Seeding NeedleIWJ · Traditional | Promex, Inc. | 11/21/1997SE |
| K963743 | Manan Prostate Uni-LockIWJ · Traditional | Manan Medical Products, Inc. | 12/06/1996SE |
| K951052 | Weeks ApplicatorIWJ · Traditional | Duke University Medical Center | 08/22/1996SE |
More from Duke University Medical Center
| 510(k) | Device | Decision |
|---|---|---|
| K230155 | Mick Valencia Applicator SetJAQ · Traditional | 08/30/2023SE |
| K200221 | CT F/S/D Compatible Applicators (Fletcher), HDR Compatible Tandem and Ovoid Applicators…JAQ · Special | 02/28/2020SE |
| 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 |
Questions and answers
When was Hilaris-Nori Endometrial Applicator cleared by the FDA?
Hilaris-Nori Endometrial Applicator (K871216) received a 510(k) decision of Substantially Equivalent on July 21, 1987, 117 days after the submission was received.
What is the product code of K871216?
The FDA product code is IWJ – System, Applicator, Radionuclide, Manual, a Class I (low risk) device regulated under 21 CFR 892.5650.