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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 the device name listed in this FDA 510(k) record. The listed applicant is Focal Therapeutics. It received FDA 510(k) clearance on 2019-09-26 under 510(k) 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. The listed applicant is Focal Therapeutics. The 510(k) number is K192371.

When did BioZorb SP Marker receive FDA 510(k) clearance?

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

Who is the listed applicant for BioZorb SP Marker?

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 SP Marker?

The FDA product code for BioZorb SP Marker is NEU.

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.

K171467BioZorb Marker GOLD / LP Marker GOLD

Related Devices (Code: NEU)

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.

K253761HydroMARK™ Plus Breast Biopsy Site Marker (Dragonfly Shape); HydroMARK™ Plus Breast Biopsy Site Marker (Hummingbird Shape)Devicor Medical Products, Inc.K253888MOLLI 2 SystemStryker EndoscopyK252892SCOUT MD Surgical Guidance SystemMerit Medical Systems, Inc.K251989VizMark Preloaded Tissue Marker Device (VM-0001)Breast-Med, Inc.K251748MammoSTAR Biopsy Site IdentifierCarbon Medical Technologies, Inc.K243642UltraCor™ Twirl™ Breast Tissue MarkerBard Peripheral Vascular, Inc.

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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