Manan Prostate Uni-Lock
FDA 510(k) K963743 · Manan Medical Products, Inc.
510(k) numberK963743
Submission
- Device name
- Manan Prostate Uni-Lock
- Applicant
- Manan Medical Products, Inc.
Northbrook, IL, US - Received
- September 17, 1996
- Decision date
- December 6, 1996
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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| 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 |
| 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 |
|---|---|---|
| K052802 | Manan Bio-Cut Soft Tissue Biopsy NeedleKNW · Special | 11/01/2005SE |
| K011209 | Manan Spritacre Spinal NeedlesBSP · Traditional | 06/26/2001SE |
| K983620 | Manan Spinal NeedlesBSP · Traditional | 01/08/1999SE |
| K980536 | Epidural NeedleBSP · Traditional | 07/31/1998SE |
| K981386 | Manan Blunt NeedleFPA · Traditional | 06/29/1998SE |
| K980211 | MRI Chiba,Spinal,Breast Localization,Automatic Cutting NeedlesKNW · Traditional | 02/06/1998SE |
| K974446 | Manan Automatic Cutting NeedleKNW · Traditional | 01/08/1998SE |
| K962977 | MRI Compatible Biopsy NeedlesKNW · Traditional | 10/09/1997SE |
| K963767 | Manan V.S. Access Needle/SetFGE · Traditional | 05/16/1997SE |
| K961986 | Manan D BagEXF · Traditional | 03/13/1997SE |
Questions and answers
When was Manan Prostate Uni-Lock cleared by the FDA?
Manan Prostate Uni-Lock (K963743) received a 510(k) decision of Substantially Equivalent on December 6, 1996, 80 days after the submission was received.
What is the product code of K963743?
The FDA product code is IWJ – System, Applicator, Radionuclide, Manual, a Class I (low risk) device regulated under 21 CFR 892.5650.