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FDA 510(k)

BioZorb Marker GOLD / LP Marker GOLD

K-Number: K171467 · 2017-11-09

ApplicantFocal Therapeutics
Decision Date2017-11-09
Product CodeIYE
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

BioZorb Marker GOLD / LP Marker GOLD is the device name listed in this FDA 510(k) record. The listed applicant is Focal Therapeutics. It received FDA 510(k) clearance on 2017-11-09 under 510(k) number K171467. The device is classified under product code IYE. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BioZorb Marker GOLD / LP Marker GOLD?

BioZorb Marker GOLD / LP Marker GOLD is a medical device that received FDA 510(k) clearance on 2017-11-09. The listed applicant is Focal Therapeutics. The 510(k) number is K171467.

When did BioZorb Marker GOLD / LP Marker GOLD receive FDA 510(k) clearance?

BioZorb Marker GOLD / LP Marker GOLD received FDA 510(k) clearance on 2017-11-09, under 510(k) number K171467.

Who is the listed applicant for BioZorb Marker GOLD / LP Marker GOLD?

The FDA 510(k) record lists Focal Therapeutics as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BioZorb Marker GOLD / LP Marker GOLD?

The FDA product code for BioZorb Marker GOLD / LP Marker GOLD is IYE.

Other records listing Focal Therapeutics 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.

K192371BioZorb SP Marker

Related Devices (Code: IYE)

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.

K261856Halcyon, Ethos Radiotherapy System (5.0)Varian Medical Systems, Inc.K252937ThinkQA 3Dosisoft SAK253004LUNA 3DLap GmbH Laser ApplikationenK260792AerFrame Patient Immobilization System (AFPIS)Stabilix, LLCK252258VERIQA RT EPID 3DPtw-Freiburg Physikalisch-Technische-Werkstaetten Dr. PychlaK253962ClearCheck (RADCC V2.7)Radformation, Inc.

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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