Best Industries Cartridge & Gun
FDA 510(k) K924290 · Best Industries
510(k) numberK924290
Submission
- Device name
- Best Industries Cartridge & Gun
- Applicant
- Best Industries
Springfield, VA, US - Received
- August 21, 1992
- Decision date
- June 4, 1993
- 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 |
| 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 |
|---|---|---|
| K940121 | Implanters/Adjustable/Anderson's MarkersIWJ · Traditional | 12/30/1994SE |
| K940119 | Royal Marsden Gold Grain GunIWS · Traditional | 12/30/1994SE |
| K933410 | Implant Applicators, Cartridges/Magazines, Implanters for Permanent Implant of…IWJ · Traditional | 12/30/1994SE |
| K932242 | Radioactive Samarium 145 Seeds/Sources #2341-2345KXK · Traditional | 07/27/1993SE |
| K930570 | Radioactive Palladium 103 Seeds/SourcesKXK · Traditional | 06/04/1993SE |
| K924261 | Radioactive CESIUM-131 Seeds/SourcesKXK · Traditional | 06/04/1993SE |
| K912170 | Radioactive IODINE-125 SourcesIWI · Traditional | 08/09/1991SE |
| K910862 | Various Template ApplicatorsIWJ · Traditional | 04/18/1991SE |
Questions and answers
When was Best Industries Cartridge & Gun cleared by the FDA?
Best Industries Cartridge & Gun (K924290) received a 510(k) decision of Substantially Equivalent on June 4, 1993, 287 days after the submission was received.
What is the product code of K924290?
The FDA product code is IWJ – System, Applicator, Radionuclide, Manual, a Class I (low risk) device regulated under 21 CFR 892.5650.