FDA Product Code
FDA Product Code NEU — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- General, Plastic Surgery
- 21 CFR Citation
- 878.4300
510(k) Clearances — 110 records · page 1 of 2
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K253761 | HydroMARK Plus Breast Biopsy Site Marker (Dragonfly Shape); HydroMARK Plus Breast Biopsy Site Marker (Hummingbird Shape) | Devicor Medical Products, Inc. | 2026-01-23 | Traditional | PDF ↗ |
| K253888 | MOLLI 2 System | Stryker Endoscopy | 2025-12-31 | Special | PDF ↗ |
| K252892 | SCOUT MD Surgical Guidance System | Merit Medical Systems, Inc. | 2025-12-19 | Traditional | PDF ↗ |
| K251989 | VizMark Preloaded Tissue Marker Device (VM-0001) | Breast-Med, Inc. | 2025-12-12 | Traditional | PDF ↗ |
| K251748 | MammoSTAR Biopsy Site Identifier | Carbon Medical Technologies, Inc. | 2025-07-23 | Traditional | PDF ↗ |
| K243642 | UltraCor Twirl Breast Tissue Marker | Bard Peripheral Vascular, Inc. | 2025-03-24 | Traditional | PDF ↗ |
| K233639 | SmartClip Secure Soft Tissue Marker | Elucent Medical, Inc. | 2024-12-20 | Traditional | PDF ↗ |
| K240429 | Trilogy Tissue Marker | Inrad, Inc. | 2024-11-07 | Traditional | PDF ↗ |
| K234149 | MOLLI 2 System | Molli Surgical, Inc. | 2024-09-26 | Traditional | PDF ↗ |
| K240042 | MOLLI 2 System | Molli Surgical, Inc. | 2024-09-25 | Traditional | PDF ↗ |
| K241762 | OneMark | View Point Medical | 2024-09-16 | Traditional | PDF ↗ |
| K240527 | HydroMARK Plus Breast Biopsy Site Marker (Hummingbird Shape) (4010-02-15-T6) | Devicor Medical Products, Inc. | 2024-07-10 | Traditional | PDF ↗ |
| K232865 | Magseed Pro Magnetic Marker System | Endomagnetics Ltd., | 2024-06-28 | Traditional | PDF ↗ |
| K231468 | SCOUT MD Surgical Guidance System | Merit Medical System, Inc. | 2024-02-12 | Traditional | PDF ↗ |
| K230836 | SchurSign Tissue Marker | Surgmark GmbH | 2024-01-23 | Traditional | PDF ↗ |
| K232615 | LumiMARK Biopsy Site Marker (LM0215T (Tulip Shape)); LumiMARK Biopsy Site Marker (LM0215L (Lotus Shape)); LumiMARK Biopsy Site Marker (LM0215R (Rose shape)) | Devicor Medical Products, Inc. | 2024-01-12 | Traditional | PDF ↗ |
| K231579 | MOLLI 2 | Molli Surgical, Inc. | 2023-10-26 | Traditional | PDF ↗ |
| K221961 | HydroMARK Plus Breast Biopsy Site Marker | Devicor Medical Products, Inc. | 2023-07-13 | Traditional | PDF ↗ |
| K222832 | Sentimag System | Endomagnetics Ltd., | 2023-01-21 | Traditional | PDF ↗ |
| K223107 | MOLLI 2 | Molli Surgical, Inc. | 2023-01-18 | Traditional | PDF ↗ |
| K212158 | HydroMARK Breast Biopsy Site Marker | Devicor Medical Products, Inc. | 2022-04-21 | Traditional | PDF ↗ |
| K212882 | SCOUT BX Delivery System | Merit Medical Systems, Inc. | 2022-04-08 | Traditional | PDF ↗ |
| K210600 | MOLLI | Molli Surgical, Inc. | 2021-04-16 | Traditional | PDF ↗ |
| K210752 | HydroMARK Breast Biopsy Site Marker | Devicor Medical Products, Inc. | 2021-04-14 | Special | PDF ↗ |
| K201863 | Tumark Vision, Tumark Professional, Tumark Q, Tumark Professional Q-Shape | Somatex Medical Technologies GmbH | 2021-02-18 | Traditional | PDF ↗ |
| K203097 | HydroMARK Breast Biopsy Site Markers | Devicor Medical Products, Inc. | 2020-12-16 | Traditional | PDF ↗ |
| K192771 | C4 Fiducial Marker | C4 Imaging, LLC | 2020-10-21 | Traditional | PDF ↗ |
| K193189 | RFID Localization System | Health Beacons, Inc. | 2020-05-06 | Traditional | PDF ↗ |
| K183503 | EasyMark Tissue Marker | Inrad, Inc. | 2019-10-17 | Traditional | PDF ↗ |
| K192371 | BioZorb SP Marker | Focal Therapeutics | 2019-09-26 | Special | PDF ↗ |
| K190932 | RFID Localization System | Health Beacons, Inc. | 2019-09-13 | Traditional | PDF ↗ |
| K190689 | SignalMark Breast Marker | View Point Medical, Inc. | 2019-08-14 | Traditional | PDF ↗ |
| K183400 | EnVisio Navigation Sytem | Elucent Medical, Inc. | 2019-03-22 | Traditional | PDF ↗ |
| K182082 | Tumark for Eviva, Tumark for Brevera | Somatex Medical Technologies GmbH | 2018-10-31 | Traditional | PDF ↗ |
| K181692 | 5cm Tag Applicator, 7cm Tag Applicator, 10 cm Tag Applicator, 5 cm Tag Applicator (10 pack), 7cm Tag Applicator (10 pack), 10cm Tag Applicator (10 pack), LOCalizer Surgical Probe, LOCalizer Surgical Probe (5 pack) | Health Beacons, Inc. | 2018-09-25 | Traditional | PDF ↗ |
| K181007 | Cianna Medical SAVI Scout Reflector and SAVI Scout System | Cianna Medical, Inc. | 2018-08-02 | Traditional | PDF ↗ |
| K180621 | EchoMark, EchoMark LP | Sonavex, Inc. | 2018-06-06 | Traditional | PDF ↗ |
| K180640 | SmartClip Soft Tissue Marker | Elucent Medical, Inc. | 2018-06-04 | Traditional | PDF ↗ |
| K180443 | Tumark Vision | Somatex Medical Technologies GmbH | 2018-03-22 | Special | PDF ↗ |
| K180061 | UltraCor Twirl Breast Tissue Marker | Bard Peripheral Vascular, Inc. | 2018-03-09 | Traditional | PDF ↗ |
| K173587 | Magseed Magnetic Marker Systtem | Endomagnetics Ltd., | 2018-02-16 | Traditional | PDF ↗ |
| K171767 | Cianna Medical SAVI Scout Reflector and SAVI Scout System | Cianna Medical, Inc. | 2017-10-31 | Traditional | PDF ↗ |
| K170803 | HydroMARK Breast Biopsy Site Markers | Devicor Medical Products, Inc. | 2017-06-15 | Traditional | PDF ↗ |
| K170026 | Radiopaque Tissue Marker | Viscus Biologics, LLC | 2017-06-02 | Traditional | PDF ↗ |
| K170905 | Star Tissue Marker | Scion Medical Technologies, LLC | 2017-04-27 | Special | PDF ↗ |
| K152510 | UltraCor Twirl Breast Tissue Marker | Bard Peripheral Vascular, Inc. | 2016-05-13 | Traditional | PDF ↗ |
| K161021 | HydroMARK Breast Biopsy Site Marker | Devicor Medical Products, Inc. | 2016-05-05 | Special | PDF ↗ |
| K152586 | Beacon Fine Needle Fiducial System | Covidien, LLC | 2015-12-30 | Traditional | PDF ↗ |
| K153189 | Beacon Tissue Marker (SE) | Scion Medical Technologies, LLC | 2015-12-17 | Special | PDF ↗ |
| K152070 | BioZorb LP Marker | Focal Therapeutics | 2015-08-26 | Special | PDF ↗ |
| K151998 | TraceIT Tissue Marker - 3mL | Augmenix, Inc. | 2015-08-19 | Special | PDF ↗ |
| K143484 | BioZorb Marker | Focal Therapeutics | 2015-06-29 | Traditional | PDF ↗ |
| K133697 | BREAST-MED TISSUE MARKER | Breast-Med, Inc. | 2015-04-10 | Traditional | PDF ↗ |
| K141722 | CAREFUSION GOLD TISSUE MARKER | Care Fusion | 2015-01-23 | Traditional | PDF ↗ |
| K142198 | BNX Fine Needle Aspiration System | Covidien, LLC | 2014-10-08 | Traditional | PDF ↗ |
| K141356 | ECHO TIP ULTRA FIDUCIAL NEEDLE | Wilson-Cook Medical, Inc. | 2014-06-20 | Special | PDF ↗ |
| K140835 | GENERAL AND PLASTIC SURGERY | Scion Medical Technologies, LLC | 2014-05-20 | Special | PDF ↗ |
| K132708 | BIOMARC FIDUCIAL MARKER | Carbon Medical Technologies, Inc. | 2013-12-20 | Traditional | PDF ↗ |
| K132463 | CIANNA MEDICAL PERMANENT TISSUE MARKER AND DELIVERY SYSTEM | Cianna Medical, Inc. | 2013-12-03 | Traditional | PDF ↗ |
| K131654 | STARCHMARK BREAST TISSUE MARKER; STARCHMARK ULTRACOR BREAST TISSUE MARKER | Senorx, Inc. | 2013-06-27 | Special | PDF ↗ |
| K130763 | BEACON TISSUE MARKER | Scion Medical Technologies, LLC | 2013-05-08 | Special | PDF ↗ |
| K130537 | BIOPSY SCIENCES LLC HYDROMARK BREAST BIOPSY SITE MARKER | Biopsy Sciences, LLC | 2013-03-29 | Special | PDF ↗ |
| K121964 | MARKIT TISSUE MARKER-1ML MARKIT TISSUE MARKER-3ML MARKIT TISSUE MARKER-10ML | Augmenix, Inc. | 2013-01-23 | Traditional | PDF ↗ |
| K123911 | SENOMARK ULTRA BREAST TISSUE MARKER | C.R. Bard, Inc. | 2013-01-10 | Special | PDF ↗ |
| K121113 | BIOPSY SCIENCES, INC. HYDROMARK BREST BIOSY SITE MARKER | Biopsy Sciences, LLC | 2012-07-12 | Traditional | PDF ↗ |
| K111895 | ECHOTIP(R) ULTRA FIDUCIAL NEEDLE | Wilson-Cook Medical Inc./Cook Endoscopy | 2012-04-27 | Traditional | PDF ↗ |
| K113202 | TISSUE MARKER | Focal Therapeutics | 2012-02-28 | Traditional | PDF ↗ |
| K111692 | TUMARK FLEX FOR MAMMOTOME,TUMARK FLEX FOR ATEC | Somatex Medical Technologies GmbH | 2011-11-08 | Special | PDF ↗ |
| K103417 | HALIFAX BIOMEDICAL TANATLUM BEAD SET | Halifax Biomedical, Inc. | 2011-06-28 | Special | PDF ↗ |
| K102506 | MIXED MEDIA MARKER | Cortex Manufacturing, Inc. | 2011-01-12 | Traditional | PDF ↗ |
| K102768 | SECRMARK BIOPSY SITE MARKING SYSTEM | Hologic, Inc. | 2010-12-02 | Special | PDF ↗ |
| K102608 | SECURMARK BIOPSY SITE MARKING SYSTEM | Suros Surgical Systems, Inc. A Hologic Company | 2010-10-08 | Special | PDF ↗ |
| K093473 | KMD-MARK1 TISSUE MARKER | Kent Medical Devices, Inc. | 2010-07-02 | Traditional | PDF ↗ |
| K100994 | PRELOADED TISSUE MARKER DEVICE | Carbon Medical Technologies, Inc. | 2010-04-30 | Special | PDF ↗ |
| K093064 | TUMARK PROFESSIONAL, MODEL 271560, MR-TUMARK PROFESSIONAL, MODEL 601560 | Somatex Medical Technologies GmbH | 2010-02-17 | Traditional | PDF ↗ |
| K090581 | TANTALUM BEAD SET, MODEL P003175 | Halifax Biomedical, Inc. | 2009-08-21 | Traditional | PDF ↗ |
| K090547 | ULTRACLIP II US WING AND COIL, MODELS: 862017U, 864017U | C.R. Bard, Inc. | 2009-03-18 | Special | PDF ↗ |
| K090501 | BIOPSY SCIENCES HYDROMARK BREAST BIOPSY SITE MARKER, MODELS 4005-02-15-T1, 4005-02-15-S1, 4005-03-15-T1, 4005-03-15-S1 | Biopsy Sciences, LLC | 2009-03-05 | Special | PDF ↗ |
| K083006 | BIOPSY SCIENCES, INC., HYDROMARK BREAST BIOPSY SITE MARKER | Biopsy Sciences, LLC | 2009-02-09 | Special | PDF ↗ |
| K082278 | MAMMOMARK, MAMMOMARK MR AND CORMARK BIOPSY SITE IDENTIFIERS | Ethicon Endo-Sugery, LLC | 2008-12-16 | Traditional | PDF ↗ |
| K081085 | STARCHMARK BIOPSY SITE MARKER, MODEL STMKEC-10GSS, STMKEC-10GTR, STMKMT-11GS | Senorx, Inc. | 2008-08-01 | Traditional | PDF ↗ |
| K081170 | PROSTATE TISSUE MARKER | Senorx, Inc. | 2008-05-28 | Traditional | PDF ↗ |
| K080698 | GEL MARK ULTRACOR BIOPSY SITE MARKER, MODEL: GMUC-17GGP | Senorx, Inc. | 2008-03-31 | Special | PDF ↗ |
| K073095 | TUMARK PROFESSIONAL, MODEL 271560; MR- TUMARK PROFESSIONAL, MODEL 601560 | Somatex Medical Technologies GmbH | 2008-03-19 | Traditional | PDF ↗ |
| K072219 | CYTOPHIL TISSUE MARKER | Cytophil, Inc. | 2008-01-18 | Traditional | PDF ↗ |
| K072913 | SECURMARK BIOPSY SITE IDENTIFICATION SYSTEM | Suros Surgical Systems, Inc. A Hologic Company | 2008-01-04 | Special | PDF ↗ |
| K072216 | KAPP BARI-RING ENDOSCOPIC MARKER, MODEL K-9536 | Kapp Surgical Instrument, Inc. | 2007-11-09 | Special | PDF ↗ |
| K070436 | BIOMARC GOLD TISSUE MARKER | Carbon Medical Technologies, Inc. | 2007-03-16 | Special | PDF ↗ |
| K063238 | ULTRACLIP II WING AND ULTRACLIP II COIL | Inrad | 2007-01-30 | Traditional | PDF ↗ |
| K062528 | TISSUE SITE MARKING SYSTEM | Suros Surgical Systems, Inc. | 2007-01-26 | Traditional | PDF ↗ |
| K063193 | MODIFICATION TO BIOMARC TISSUE MARKER | Carbon Medical Technologies, Inc. | 2006-11-21 | Special | PDF ↗ |
| K060769 | HYDROMARK BIOPSY SITE MARKER | Biopsy Sciences, LLC | 2006-07-25 | Traditional | PDF ↗ |
| K053518 | INTERV BRAND V-MARK BREAST BIOPSY SITE MARKER WITH TITANIUM ANCHOR | Medical Device Technologies, Inc. | 2006-01-26 | Special | PDF ↗ |
| K050384 | KAPP BARI-RING, MODEL KS-BR-2005 | Kapp Surgical Instrument, Inc. | 2006-01-13 | Traditional | PDF ↗ |
| K051421 | INTER V BRAND V-MARK BREAST BIOPSY SITE MARKER WITH TITANIUM ANCHOR | Medical Device Technologies, Inc. | 2005-08-30 | Traditional | PDF ↗ |
| K050090 | GEL MARK V | Senorx, Inc. | 2005-02-07 | Special | PDF ↗ |
| K042296 | BIOMARC PRELOADED TISSUE MARKER DEVICE | Carbon Medical Technologies, Inc. | 2004-09-20 | Traditional | PDF ↗ |
| K042341 | ULTRACLIP II US | Inrad | 2004-09-20 | Special | PDF ↗ |
| K040990 | MODIFICATION TO SELF-DRILLING RADIOGRAPHIC MARKERS | Walter Lorenz Surgical, Inc. | 2004-05-13 | Special | PDF ↗ |
| K040706 | GEL MARK IV | Senorx, Inc. | 2004-04-08 | Special | PDF ↗ |
Product code NEU · Class II · General, Plastic Surgery. Data: openFDA.