The following data is part of a premarket notification filed by Imagyn Medical Technologies, Inc. with the FDA for Imagyn Isosleeve / Isostar Needle System.
| Device ID | K010166 |
| 510k Number | K010166 |
| Device Name: | IMAGYN ISOSLEEVE / ISOSTAR NEEDLE SYSTEM |
| Classification | System, Applicator, Radionuclide, Manual |
| Applicant | IMAGYN MEDICAL TECHNOLOGIES, INC. 8850 M-89 Richland, MI 49083 |
| Contact | Julie Powell |
| Correspondent | Julie Powell IMAGYN MEDICAL TECHNOLOGIES, INC. 8850 M-89 Richland, MI 49083 |
| Product Code | IWJ |
| CFR Regulation Number | 892.5650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-01-18 |
| Decision Date | 2001-12-03 |