K221642 is an FDA 510(k) clearance for the SIRIUS Endoscope System. This device is classified as a Laparoscope, Gynecologic (and Accessories) (Class II - Special Controls, product code HET).
Submitted by Precision Robotics (Hong Kong) Limited (Hong Kong, CN). The FDA issued a Cleared decision on December 12, 2022, 189 days after receiving the submission on June 6, 2022.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 884.1720.
| 510(k) Number | K221642 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 06, 2022 |
| Decision Date | December 12, 2022 |
| Days to Decision | 189 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | HET - Laparoscope, Gynecologic (and Accessories) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 884.1720 |