MODIFICATION TO BIOMARC TISSUE MARKER
FDA 510(k) clearance K063193 · decided 2006-11-21
Clearance details
- K-number
- K063193
- Device name
- MODIFICATION TO BIOMARC TISSUE MARKER
- Applicant
- Carbon Medical Technologies, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2006-10-20
- Decision date
- 2006-11-21
- Days to decision
- 32 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
- St. Paul, MN, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| Durasphere® Injectable Bulking Agent (P980053/S020) | Carbon Medical Technologies, Inc. | 2024-01-18 |
| Durasphere Injectable Bulking Agent (P980053/S019) | Carbon Medical Technologies, Inc. | 2022-10-27 |
| Durasphere Injectable Bulking Agent (P980053/S018) | Carbon Medical Technologies, Inc. | 2021-02-25 |
| Durasphere Injectable Bulking Agent (P980053/S017) | Carbon Medical Technologies, Inc. | 2019-08-29 |
| DURASPHERE INJECTABLE BULKING AGENT (P980053/S016) | Carbon Medical Technologies, Inc. | 2016-04-06 |
| DURASPHERE INJECTABLE BULKING AGENT (P980053/S015) | Carbon Medical Technologies, Inc. | 2013-08-19 |
| DURASPHERE INECTABLE BULKING AGENT (P980053/S014) | Carbon Medical Technologies, Inc. | 2013-03-21 |
| DURASPHERE INJECTABLE BULKING AGENT (P980053/S013) | Carbon Medical Technologies, Inc. | 2011-01-20 |