Imagyn Isosleeve / Isostar Needle System
FDA 510(k) K010166 · Imagyn Medical Technologies, Inc.
510(k) numberK010166
Submission
- Device name
- Imagyn Isosleeve / Isostar Needle System
- Applicant
- Imagyn Medical Technologies, Inc.
Richland, MI, US - Received
- January 18, 2001
- Decision date
- December 3, 2001
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Other 510(k)s with product code IWJ
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|---|---|---|---|
| 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 |
| K961377 | Manan Prostate Locking Introducer SetIWJ · Traditional | Manan Medical Products, Inc. | 07/03/1996SE |
More from Manan Medical Products, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K032491 | Ecom CV4 Endotracheal Cardiac Output MonitorDSB · Special | 09/04/2003SESU |
| K012706 | IM2001 Pulse OximeterDQA · Traditional | 03/07/2003SE |
| K991526 | Isostar I-125 Interstitial Seed, Model IS-12501KXK · Special | 06/17/1999SE |
| K980096 | Oac (Optical Aspirating Curette)HCY · Traditional | 05/01/1998SE |
| K980291 | Impower External Vacuum SystemLKY · Traditional | 03/11/1998SE |
| K974173 | Erecaid System/Stay Erec SystemLKY · Traditional | 02/25/1998SE |
Questions and answers
When was Imagyn Isosleeve / Isostar Needle System cleared by the FDA?
Imagyn Isosleeve / Isostar Needle System (K010166) received a 510(k) decision of Substantially Equivalent on December 3, 2001, 319 days after the submission was received.
What is the product code of K010166?
The FDA product code is IWJ – System, Applicator, Radionuclide, Manual, a Class I (low risk) device regulated under 21 CFR 892.5650.