Prostate Seeding Needle
FDA 510(k) K973184 · Promex, Inc.
510(k) numberK973184
Submission
- Device name
- Prostate Seeding Needle
- Applicant
- Promex, Inc.
Indianapolis, IN, US - Received
- August 25, 1997
- Decision date
- November 21, 1997
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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 |
| 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 |
|---|---|---|
| K023450 | Biopsy Site Tissue Marker DeviceNEU · Traditional | 12/19/2002SE |
| K022634 | Co-Axial Introducer NeedleDYB · Traditional | 11/06/2002SE |
| K010400 | Vacuum Assisted Core Biopsy DeviceKNW · Traditional | 07/24/2001SE |
| K011270 | Automated Core Biopsy DeviceFCG · Traditional | 06/22/2001SE |
| K001132 | Bone Biopsy NeedleKNW · Traditional | 05/01/2000SE |
| K994272 | Automated Core Biopsy DeviceKNW · Traditional | 01/07/2000SE |
| K993435 | Manual Bone Marrow Biopsy DeviceKNW · Traditional | 12/06/1999SE |
| K972865 | Promex ENT Tissue Removal SystemERL · Traditional | 09/29/1997SE |
| K961078 | Automated Vitrectomy DeviceHQE · Traditional | 06/14/1996SE |
| K960023 | Kirshner Wires (K-Wire) & Steinmann PinsJDW · Traditional | 03/18/1996SE |
Questions and answers
When was Prostate Seeding Needle cleared by the FDA?
Prostate Seeding Needle (K973184) received a 510(k) decision of Substantially Equivalent on November 21, 1997, 88 days after the submission was received.
What is the product code of K973184?
The FDA product code is IWJ – System, Applicator, Radionuclide, Manual, a Class I (low risk) device regulated under 21 CFR 892.5650.