CARBONET ODOUR ADSORBING DRESSING
FDA 510(k) clearance K863931 · decided 1986-12-01
Clearance details
- K-number
- K863931
- Device name
- CARBONET ODOUR ADSORBING DRESSING
- Applicant
- Smith & Nephew, Inc.
- Decision
- Substantially Equivalent for Some Indications
- Date received
- 1986-10-08
- Decision date
- 1986-12-01
- Days to decision
- 54 days
- Clearance type
- Traditional
- Advisory committee
- Unknown
- Location
- Massillon, OH, 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 |
|---|---|---|
| Ascension MCP (P000057/S013) | Smith & Nephew, Inc. | 2025-12-31 |
| ASCENSION MCP (P000057/S014) | Smith & Nephew, Inc. | 2025-08-05 |
| R3 Delta Ceramic Acetabular System (P150030/S049) | Smith & Nephew, Inc. | 2025-04-17 |
| R3 DELTA CERAMIC HIP SYSTEM (P150030/S048) | Smith & Nephew, Inc. | 2025-03-03 |
| R3 Delta Ceramic Hip System (P150030/S045) | Smith & Nephew, Inc. | 2025-02-28 |
| R3 Delta Ceramic Acetabular System (P150030/S047) | Smith & Nephew, Inc. | 2025-02-21 |
| R3 Delta Ceramic Acetabular System (P150030/S046) | Smith & Nephew, Inc. | 2025-01-16 |
| BIRMINGHAM HIP RESURFACING (BHR) SYSTEM (P040033/S039) | Smith & Nephew, Inc. | 2025-01-10 |