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FDA 510(k)

Sirius Pintuition Seed, Sirius Pintuition Probe, Sirius Pintuition Base Unit

K-Number: K223682 · 2023-11-09

ApplicantSirius Medical Systems B.V.
Decision Date2023-11-09
Product CodePBY
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Sirius Pintuition Seed, Sirius Pintuition Probe, Sirius Pintuition Base Unit is a medical device manufactured by Sirius Medical Systems B.V.. It received FDA 510(k) clearance on 2023-11-09 under approval number K223682. The device is classified under product code PBY. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Sirius Pintuition Seed, Sirius Pintuition Probe, Sirius Pintuition Base Unit?

Sirius Pintuition Seed, Sirius Pintuition Probe, Sirius Pintuition Base Unit is a medical device that received FDA 510(k) clearance on 2023-11-09. It is manufactured by Sirius Medical Systems B.V.. The 510(k) number is K223682.

When was Sirius Pintuition Seed, Sirius Pintuition Probe, Sirius Pintuition Base Unit approved by the FDA?

Sirius Pintuition Seed, Sirius Pintuition Probe, Sirius Pintuition Base Unit received FDA 510(k) clearance on 2023-11-09, under approval number K223682.

What company makes Sirius Pintuition Seed, Sirius Pintuition Probe, Sirius Pintuition Base Unit?

Sirius Pintuition Seed, Sirius Pintuition Probe, Sirius Pintuition Base Unit is manufactured by Sirius Medical Systems B.V..

What is the FDA product code for Sirius Pintuition Seed, Sirius Pintuition Probe, Sirius Pintuition Base Unit?

The FDA product code for Sirius Pintuition Seed, Sirius Pintuition Probe, Sirius Pintuition Base Unit is PBY.

Other Devices by Sirius Medical Systems B.V.

K200734Sirius Pintuition Seed, Sirius Pintuition Probe, Sirius Pintuition Base Unit K222643Sirius Pintuition Seed, Sirius Pintuition Probe, Sirius Pintuition Base Unit

Related Devices (Code: PBY)

K153044Sentimag System, Sentimark Magnetic Marker SystermEndomagnetics Ltd., K163667RFID 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)Health Beacons, Inc. K163541Magseed Magnetic Marker SystemEndomagnetics Ltd., K200734Sirius Pintuition Seed, Sirius Pintuition Probe, Sirius Pintuition Base UnitSirius Medical Systems B.V. K222643Sirius Pintuition Seed, Sirius Pintuition Probe, Sirius Pintuition Base UnitSirius Medical Systems B.V.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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