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FDA 510(k)

BioZorb SP Marker

K-Number: K192371 · 2019-09-26

ApplicantFocal Therapeutics
Decision Date2019-09-26
Product CodeNEU
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

BioZorb SP Marker is a medical device manufactured by Focal Therapeutics. It received FDA 510(k) clearance on 2019-09-26 under approval number K192371. The device is classified under product code NEU. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BioZorb SP Marker?

BioZorb SP Marker is a medical device that received FDA 510(k) clearance on 2019-09-26. It is manufactured by Focal Therapeutics. The 510(k) number is K192371.

When was BioZorb SP Marker approved by the FDA?

BioZorb SP Marker received FDA 510(k) clearance on 2019-09-26, under approval number K192371.

What company makes BioZorb SP Marker?

BioZorb SP Marker is manufactured by Focal Therapeutics.

What is the FDA product code for BioZorb SP Marker?

The FDA product code for BioZorb SP Marker is NEU.

Other Devices by Focal Therapeutics

K171467BioZorb Marker GOLD / LP Marker GOLD

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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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