Sirius Pintuition Seed, Sirius Pintuition Probe, Sirius Pintuition Base Unit— 510(k) K200734
Substantially EquivalentSirius Medical Systems B.V.
FDA 510(k) clearance K200734 for Sirius Pintuition Seed, Sirius Pintuition Probe, Sirius Pintuition Base Unit, Substantially Equivalent on 2021-02-24. Applicant: Sirius Medical Systems B.V.. Device class: 2.
Clearance details
- Applicant
- Sirius Medical Systems B.V.
- Product code
- Code PBY
- Device class
- Class 2
- Regulation
- 21 CFR 878.4300
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Eindhoven, NL
Recent devices under product code PBY
view all- K223682 — Sirius Pintuition Seed, Sirius Pintuition Probe, Sirius Pintuition Base Unit
- K222643 — Sirius Pintuition Seed, Sirius Pintuition Probe, Sirius Pintuition Base Unit
- K163667 — RFID Localization System- Localizer Reader, RFID Localization System- Localizer Surgical Probe, RFID Localization System- Localizer Surgical Probe (5 pack), RFID Localization System- Tag Applicator, RFID Localization System -Tag Applicator (10 pack)
- K163541 — Magseed Magnetic Marker System
- K153044 — Sentimag System, Sentimark Magnetic Marker Systerm
Data sourced from openFDA. This site is unofficial and independent of the FDA.