Tumark Professional, Model 271560, Mr-Tumark Professional, Model 601560
FDA 510(k) K093064 · Somatex Medical Technologies GmbH
510(k) numberK093064
Submission
- Device name
- Tumark Professional, Model 271560, Mr-Tumark Professional, Model 601560
- Applicant
- Somatex Medical Technologies GmbH
Cambridge, MA, US - Received
- September 30, 2009
- Decision date
- February 17, 2010
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- NEU – Marker, Radiographic, Implantable
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.4300
- Specialty
- General, Plastic Surgery
- Implant
- Yes
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|---|---|---|---|
| K253761 | HydroMARK Plus Breast Biopsy Site Marker (Dragonfly Shape); HydroMARK Plus Breast…NEU · Traditional | Devicor Medical Products, Inc. | 01/23/2026SE |
| K253888 | MOLLI 2 SystemNEU · Special | Stryker Endoscopy | 12/31/2025SE |
| K252892 | SCOUT MD Surgical Guidance SystemNEU · Traditional | Merit Medical Systems, Inc. | 12/19/2025SE |
| K251989 | VizMark Preloaded Tissue Marker Device (VM-0001)NEU · Traditional | Breast-Med, Inc. | 12/12/2025SE |
| K251748 | MammoSTAR Biopsy Site IdentifierNEU · Traditional | Carbon Medical Technologies, Inc. | 07/23/2025SE |
| K243642 | UltraCor Twirl Breast Tissue MarkerNEU · Traditional | Bard Peripheral Vascular, Inc. | 03/24/2025SE |
| K233639 | SmartClip Secure Soft Tissue MarkerNEU · Traditional | Elucent Medical, Inc. | 12/20/2024SE |
| K240429 | Trilogy Tissue MarkerNEU · Traditional | Inrad, Inc. | 11/07/2024SE |
| K234149 | MOLLI 2 SystemNEU · Traditional | Molli Surgical, Inc. | 09/26/2024SE |
| K240042 | MOLLI 2 SystemNEU · Traditional | Molli Surgical, Inc. | 09/25/2024SE |
More from Molli Surgical, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K201863 | Tumark Vision, Tumark Professional, Tumark Q, Tumark Professional Q-ShapeNEU · Traditional | 02/18/2021SE |
| K182082 | Tumark for Eviva, Tumark for BreveraNEU · Traditional | 10/31/2018SE |
| K180443 | Tumark VisionNEU · Special | 03/22/2018SE |
| K111692 | Tumark Flex for Mammotome,Tumark Flex for AtecNEU · Special | 11/08/2011SE |
| K102771 | Biopsy Handy, MRI Biopsy HandyKNW · Traditional | 06/24/2011SE |
| K073095 | Tumark Professional, Model 271560; Mr- Tumark Professional, Model 601560NEU · Traditional | 03/19/2008SE |
Questions and answers
When was Tumark Professional, Model 271560, Mr-Tumark Professional, Model 601560 cleared by the FDA?
Tumark Professional, Model 271560, Mr-Tumark Professional, Model 601560 (K093064) received a 510(k) decision of Substantially Equivalent on February 17, 2010, 140 days after the submission was received.
What is the product code of K093064?
The FDA product code is NEU – Marker, Radiographic, Implantable, a Class II (moderate risk) device regulated under 21 CFR 878.4300.