SECRMARK BIOPSY SITE MARKING SYSTEM
FDA 510(k) clearance K102768 · decided 2010-12-02
Clearance details
- K-number
- K102768
- Device name
- SECRMARK BIOPSY SITE MARKING SYSTEM
- Applicant
- Hologic, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2010-09-24
- Decision date
- 2010-12-02
- Days to decision
- 69 days
- Clearance type
- Special
- Product code
- NEU
- Device class
- 2
- Regulation number
- 878.4300
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Indianapolis, IN, US
- Third-party review
- No
- Expedited review
- No
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Devices cleared under the same product code - the starting set for predicate research.
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|---|---|---|
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| MammoSTAR Biopsy Site Identifier (K251748) | Carbon Medical Technologies, Inc. | 2025-07-23 |
| UltraCor™ Twirl™ Breast Tissue Marker (K243642) | Bard Peripheral Vascular, Inc. | 2025-03-24 |
| SmartClip Secure Soft Tissue Marker (K233639) | Elucent Medical, Inc. | 2024-12-20 |
| Trilogy Tissue Marker (K240429) | Inrad, Inc. | 2024-11-07 |
| MOLLI 2 System (K234149) | Molli Surgical, Inc. | 2024-09-26 |
| MOLLI 2 System (K240042) | Molli Surgical, Inc. | 2024-09-25 |
| OneMark (K241762) | View Point Medical | 2024-09-16 |
| HydroMARK™ Plus Breast Biopsy Site Marker (Hummingbird Shape) (4010-02-15-T6) (K240527) | Devicor Medical Products, Inc. | 2024-07-10 |
Recalls involving this device
No recalls on record reference this clearance.
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