Reganes Radionuclide Seed Magazine
FDA 510(k) K972554 · Avid N.I.T., Inc.
510(k) numberK972554
Submission
- Device name
- Reganes Radionuclide Seed Magazine
- Applicant
- Avid N.I.T., Inc.
Tarpon Springs, FL, US - Received
- July 8, 1997
- Decision date
- February 17, 1998
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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| 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 |
| K961377 | Manan Prostate Locking Introducer SetIWJ · Traditional | Manan Medical Products, Inc. | 07/03/1996SE |
More from Manan Medical Products, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K014246 | Avid-Nit Nerve Stimulation NeedlesCAZ · Traditional | 07/16/2002SE |
| K013231 | Avid-Nit Plastic Hub Lutz Epidural Needle,Model RP2035L, Avid-Nit Metal Hub Lutz…BSP · Traditional | 12/03/2001SE |
| K983218 | N,I.T., Inc. Automatic Cutting Biopsy NeedleFCG · Traditional | 11/06/1998SE |
| K972595 | Aldrete Epidural Needle Without IntroducerBSP · Traditional | 05/20/1998SE |
| K973037 | N.I.T., Inc. Radionuclide Seed Applicator, Model SA-1000IWJ · Traditional | 01/27/1998SE |
| K973638 | N.I.T., Inc. Needle Guiding TemplateIWJ · Traditional | 12/23/1997SE |
| K971645 | Reganes Spinal Needle (Various)MIA · Traditional | 08/01/1997SE |
| K945965 | Atraumatic Pencil Point Spinal NeedleBSP · Traditional | 08/02/1995SE |
Questions and answers
When was Reganes Radionuclide Seed Magazine cleared by the FDA?
Reganes Radionuclide Seed Magazine (K972554) received a 510(k) decision of Substantially Equivalent on February 17, 1998, 224 days after the submission was received.
What is the product code of K972554?
The FDA product code is IWJ – System, Applicator, Radionuclide, Manual, a Class I (low risk) device regulated under 21 CFR 892.5650.