HET
- Product code
- HET
- Device name
- Laparoscope, Gynecologic (And Accessories)
- Device class
- Class 2
- 21 CFR
- 21 CFR 884.1720
- Medical specialty
- Obstetrics/Gynecology
- Marketing pathway
- 510(K)
- 510(k) clearances (last 3 years)
- 2
- Summaries archived here
- 2 (direct download)
- 510(k) clearances (all years, FDA)
- 338 (all years; only the last 3 years are listed here)
510(k) clearances, last 3 years (2)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K250939 | 2025-08-29 | Precision Robotics (Hong Kong) Limited | SIRIUS Endoscope System (PR-SI-1230) | |
| K243821 | 2025-04-25 | A.M.I. Agency For Medical Innovations … | i-Cut |
Official FDA classification page: HET
Classification and pathway per current FDA publications. Data from openFDA (CC0).