K222643 is an FDA 510(k) clearance for the Sirius Pintuition Seed, Sirius Pintuition Probe, Sirius Pintuition Base Unit. This device is classified as a Temporary Tissue Marker (Class II - Special Controls, product code PBY).
Submitted by Sirius Medical Systems B.V. (Eindhoven, NL). The FDA issued a Cleared decision on October 19, 2022, 48 days after receiving the submission on September 1, 2022.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4300. To Temporarily (< 30 Days) Mark A Tissue Site Intended For Surgical Removal. The Tissue Marker Is Surgically Removed With The Target Tissue..
| 510(k) Number | K222643 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 01, 2022 |
| Decision Date | October 19, 2022 |
| Days to Decision | 48 days |
| Submission Type | Special |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | PBY - Temporary Tissue Marker |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.4300 |
| Definition | To Temporarily (< 30 Days) Mark A Tissue Site Intended For Surgical Removal. The Tissue Marker Is Surgically Removed With The Target Tissue. |