K233043 is an FDA 510(k) clearance for the Smart Scope® CX. This device is classified as a Colposcope (and Colpomicroscope) (Class II - Special Controls, product code HEX).
Submitted by Periwinkle Technologies Pvt., Ltd. (Pune, IN). The FDA issued a Cleared decision on June 14, 2024, 263 days after receiving the submission on September 25, 2023.
This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.1630.
| 510(k) Number | K233043 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 25, 2023 |
| Decision Date | June 14, 2024 |
| Days to Decision | 263 days |
| Submission Type | Traditional |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | Summary PDF |
| Product Code | HEX - Colposcope (and Colpomicroscope) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 884.1630 |