The following data is part of a premarket notification filed by Uvision360 Inc. with the FDA for Luminelle Dtx Hysteroscopy System, Luminelle Dx 360 Rotatable Disposable Sheath (diagnostic).
| Device ID | K192278 |
| 510k Number | K192278 |
| Device Name: | Luminelle DTx Hysteroscopy System, Luminelle Dx 360 Rotatable Disposable Sheath (Diagnostic) |
| Classification | Hysteroscope (and Accessories) |
| Applicant | UVision360 Inc. 158 Wind Chime Ct. Ste. 201 Raleigh, NC 27615 |
| Contact | Allison London Brown |
| Correspondent | Rita King MethodSense, Inc. 1 Copley Pkwy, Ste. 410 Morrisville, NC 27560 |
| Product Code | HIH |
| CFR Regulation Number | 884.1690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-08-22 |
| Decision Date | 2019-11-01 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00853277008060 | K192278 | 000 |