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FDA 510(k)

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

K-Number: K200734 · 2021-02-24

ApplicantSirius Medical Systems B.V.
Decision Date2021-02-24
Product CodePBY
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Sirius Pintuition Seed, Sirius Pintuition Probe, Sirius Pintuition Base Unit is the device name listed in this FDA 510(k) record. The listed applicant is Sirius Medical Systems B.V.. It received FDA 510(k) clearance on 2021-02-24 under 510(k) number K200734. 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 2021-02-24. The listed applicant is Sirius Medical Systems B.V.. The 510(k) number is K200734.

When did Sirius Pintuition Seed, Sirius Pintuition Probe, Sirius Pintuition Base Unit receive FDA 510(k) clearance?

Sirius Pintuition Seed, Sirius Pintuition Probe, Sirius Pintuition Base Unit received FDA 510(k) clearance on 2021-02-24, under 510(k) number K200734.

Who is the listed applicant for Sirius Pintuition Seed, Sirius Pintuition Probe, Sirius Pintuition Base Unit?

The FDA 510(k) record lists Sirius Medical Systems B.V. as the applicant. This does not by itself establish the device manufacturer.

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 records listing Sirius Medical Systems B.V. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K223682Sirius Pintuition Seed, Sirius Pintuition Probe, Sirius Pintuition Base UnitK222643Sirius Pintuition Seed, Sirius Pintuition Probe, Sirius Pintuition Base Unit

Related Devices (Code: PBY)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K223682Sirius 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.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.,K153044Sentimag System, Sentimark Magnetic Marker SystermEndomagnetics Ltd.,

Official Source

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

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