Durasphere Injectable Bulking Agent
FDA premarket approval P980053/S021 · decided 2026-03-13
Approval details
- PMA number
- P980053
- Supplement
- S021
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Durasphere Injectable Bulking Agent
- Generic name
- AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE
- Applicant
- Carbon Medical Technologies, Inc.
- Date received
- 2025-01-23
- Decision date
- 2026-03-13
- Days to decision
- 414 days
- Decision code
- APPR
- Product code
- LNM
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- St. Paul, MN
- Statement
- a change to the syringe cap of the 1 mL Durasphere device configuration
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| InjecSURE Injection System (K253598) | Carbon Medical Technologies, Inc. | 2026-03-31 |
| MammoSTAR Biopsy Site Identifier (K251748) | Carbon Medical Technologies, Inc. | 2025-07-23 |
| Fiducial Marker (K211590) | Carbon Medical Technologies, Inc. | 2021-06-10 |
| Endoscopic Injection Needle (K172227) | Carbon Medical Technologies, Inc. | 2017-08-23 |
| BIOMARC COAXIAL NEEDLE (K133148) | Carbon Medical Technologies, Inc. | 2014-05-13 |
| BIOMARC FIDUCIAL MARKER (K132064) | Carbon Medical Technologies, Inc. | 2014-02-28 |
| BIOMARC FIDUCIAL MARKER (K132708) | Carbon Medical Technologies, Inc. | 2013-12-20 |
| BIOMARC GOLD FIDUCIAL MARKER (K130678) | Carbon Medical Technologies, Inc. | 2013-04-12 |