K193007 is an FDA 510(k) clearance for the LiNA OperaScope with HDMI cable and on-board LCD - 6 units, LiNA OperaScope Recording Module. This device is classified as a Hysteroscope (and Accessories) (Class II - Special Controls, product code HIH).
Submitted by Lina Medical Aps (Glostrup, DK). The FDA issued a Cleared decision on January 17, 2020, 81 days after receiving the submission on October 28, 2019.
This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.1690.
| 510(k) Number | K193007 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 28, 2019 |
| Decision Date | January 17, 2020 |
| Days to Decision | 81 days |
| Submission Type | Traditional |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | Summary PDF |
| Product Code | HIH - Hysteroscope (and Accessories) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 884.1690 |