Browse hierarchy: [General, Plastic Surgery (SU)](/submissions/SU) → [Subpart E — Surgical Devices](/submissions/SU/subpart-e%E2%80%94surgical-devices) → [21 CFR 878.4300](/submissions/SU/subpart-e%E2%80%94surgical-devices/878.4300) → NEU — Marker, Radiographic, Implantable # NEU · Marker, Radiographic, Implantable _General, Plastic Surgery · 21 CFR 878.4300 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/NEU ## Overview - **Product Code:** NEU - **Device Name:** Marker, Radiographic, Implantable - **Regulation:** [21 CFR 878.4300](/submissions/SU/subpart-e%E2%80%94surgical-devices/878.4300) - **Device Class:** 2 - **Review Panel:** [General, Plastic Surgery](/submissions/SU) - **Implant:** yes ## Identification An implantable clip is a clip-like device intended to connect internal tissues to aid healing. It is not absorbable. ## Classification Rationale Class II. ## Recent Cleared Devices (20 of 110) Showing 20 most recent of 110 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K253761](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/NEU/K253761.md) | HydroMARK™ Plus Breast Biopsy Site Marker (Dragonfly Shape); HydroMARK™ Plus Breast Biopsy Site Marker (Hummingbird Shape) | Devicor Medical Products, Inc. | Jan 23, 2026 | SESE | | [K253888](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/NEU/K253888.md) | MOLLI 2 System | Stryker Endoscopy | Dec 31, 2025 | SESE | | [K252892](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/NEU/K252892.md) | SCOUT MD Surgical Guidance System | Merit Medical Systems, Inc. | Dec 19, 2025 | SESE | | [K251989](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/NEU/K251989.md) | VizMark Preloaded Tissue Marker Device (VM-0001) | Breast-Med, Inc. | Dec 12, 2025 | SESE | | [K251748](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/NEU/K251748.md) | MammoSTAR Biopsy Site Identifier | Carbon Medical Technologies, Inc. | Jul 23, 2025 | SESE | | [K243642](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/NEU/K243642.md) | UltraCor™ Twirl™ Breast Tissue Marker | Bard Peripheral Vascular, Inc. | Mar 24, 2025 | SESE | | [K233639](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/NEU/K233639.md) | SmartClip Secure Soft Tissue Marker | Elucent Medical, Inc. | Dec 20, 2024 | SESE | | [K240429](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/NEU/K240429.md) | Trilogy Tissue Marker | Inrad, Inc. | Nov 7, 2024 | SESE | | [K234149](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/NEU/K234149.md) | MOLLI 2 System | Molli Surgical, Inc. | Sep 26, 2024 | SESE | | [K240042](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/NEU/K240042.md) | MOLLI 2 System | Molli Surgical, Inc. | Sep 25, 2024 | SESE | | [K241762](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/NEU/K241762.md) | OneMark | View Point Medical | Sep 16, 2024 | SESE | | [K240527](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/NEU/K240527.md) | HydroMARK™ Plus Breast Biopsy Site Marker (Hummingbird Shape) (4010-02-15-T6) | Devicor Medical Products, Inc. | Jul 10, 2024 | SESE | | [K232865](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/NEU/K232865.md) | Magseed Pro Magnetic Marker System | Endomagnetics Ltd., | Jun 28, 2024 | SESE | | [K231468](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/NEU/K231468.md) | SCOUT MD Surgical Guidance System | Merit Medical System, Inc. | Feb 12, 2024 | SESE | | [K230836](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/NEU/K230836.md) | SchurSign Tissue Marker | Surgmark GmbH | Jan 23, 2024 | SESE | | [K232615](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/NEU/K232615.md) | 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. | Jan 12, 2024 | SESE | | [K231579](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/NEU/K231579.md) | MOLLI 2 | Molli Surgical, Inc. | Oct 26, 2023 | SESE | | [K221961](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/NEU/K221961.md) | HydroMARK Plus Breast Biopsy Site Marker | Devicor Medical Products, Inc. | Jul 13, 2023 | SESE | | [K222832](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/NEU/K222832.md) | Sentimag System | Endomagnetics Ltd., | Jan 21, 2023 | SESE | | [K223107](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/NEU/K223107.md) | MOLLI 2 | Molli Surgical, Inc. | Jan 18, 2023 | SESE | ## Top Applicants - Devicor Medical Products, Inc. — 9 clearances - Senorx, Inc. — 7 clearances - Somatex Medical Technologies GmbH — 6 clearances - Carbon Medical Technologies, Inc. — 6 clearances - Biopsy Sciences, LLC — 6 clearances --- **Source:** [https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/NEU](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/NEU) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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