TraceIT Tissue Marker - 3mL
FDA 510(k) clearance K151998 · decided 2015-08-19
Clearance details
- K-number
- K151998
- Device name
- TraceIT Tissue Marker - 3mL
- Applicant
- Augmenix, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2015-07-20
- Decision date
- 2015-08-19
- Days to decision
- 30 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
- Waltham, MA, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Augmenix
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| HydroMARK™ Plus Breast Biopsy Site Marker (Dragonfly Shape); HydroMARK™ Plus Breast Biopsy Site Marker (Hummingbird Shape) (K253761) | Devicor Medical Products, Inc. | 2026-01-23 |
| MOLLI 2 System (K253888) | Stryker Endoscopy | 2025-12-31 |
| SCOUT MD Surgical Guidance System (K252892) | Merit Medical Systems, Inc. | 2025-12-19 |
| VizMark Preloaded Tissue Marker Device (VM-0001) (K251989) | Breast-Med, Inc. | 2025-12-12 |
| 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.