BioZorb LP Marker— 510(k) K152070

Clearance details

Applicant

Focal Therapeutics

Product code

Code NEU

Device class

Class 2

Regulation

21 CFR 878.4300

Advisory panel

General, Plastic Surgery

Date received

2015-07-27

Decision date

2015-08-26

Decision

Substantially Equivalent

Clearance type

Special

Location

Portola Valley, CA, US

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• K251989 — VizMark Preloaded Tissue Marker Device (VM-0001)2025-12-12
• K251748 — MammoSTAR Biopsy Site Identifier2025-07-23

• K192371 — BioZorb SP Marker2019-09-26
• K171467 — BioZorb Marker GOLD / LP Marker GOLD2017-11-09
• K143484 — BioZorb Marker2015-06-29
• K113202 — TISSUE MARKER2012-02-28

Injury

824

Total

824

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

• Z-0328-2025 — BioZorb Marker. Radiographic soft tissue marker.Class I·Ongoing·Hologic, Inc·20241010
• Z-1733-2024 — BioZorb Marker-BioZorb 3D Bioabsorbable Marker-Intended Use radiographic marking of sites in soft tissue. 1) F0405 BioZorb Marker 4cm x 5cm 2) F0404 BioZorb Marker 4cm x 4cm 3) F0331 BioZorb Marker 1cm x 3cm x 3cm 4) F0231 BioZorb Marker 1cm x 3cm x 2cm 5) F0221 BioZorb Marker 1cm x 3cm x 2cm 6) F0304 BioZorb Marker 3cm x 4cm 7) F0303 BioZorb Marker 3cm x 3cm 8) F0203 BioZorb Marker 2cm x 3cm 9) F0202 BioZorb Marker 2cm x 2cmClass I·Ongoing·Hologic, Inc·20240313
• Z-1858-2022 — The BioZorb LP Marker is an implantable radiopaque marker used to facilitate visualization of a soft tissue site. The BioZorb LP Marker is comprised of a bioabsorbable PLA (polylactic acid) component which resorbs completely in 1 year or more and a permanent component (titanium). The BioZorb LP Marker is provided sterile for single use and is implantable.Class II·Ongoing·Hologic, Inc·20220809

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K152070.