SMITH & NEPHEW DYONICS ELECTROBLADE RESECTOR
FDA 510(k) clearance K031675 · decided 2003-06-20
Clearance details
- K-number
- K031675
- Device name
- SMITH & NEPHEW DYONICS ELECTROBLADE RESECTOR
- Applicant
- Smith & Nephew, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2003-05-30
- Decision date
- 2003-06-20
- Days to decision
- 21 days
- Clearance type
- Special
- Product code
- GEI
- Device class
- 2
- Regulation number
- 878.4400
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Andover, MA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Dyonics Electroblade, 4.5 Full Radius, Valleylab Generator-Compatible Part Number: 7205961 recall (Z-1230-06) | Smith & Nephew, Inc. Endoscopy Division | 2006-07-13 |
| Dyonics Electroblade 4.5 ELITE, Full Radius, Valleylab Generator- Compatible Part Number: recall (Z-1231-06) | Smith & Nephew, Inc. Endoscopy Division | 2006-07-13 |
| Dyonics Electroblade 4.5 Full Radius, VULCAN Generator-Compatible Product number: 7209855 recall (Z-1232-06) | Smith & Nephew, Inc. Endoscopy Division | 2006-07-13 |
| Dyonics Electroblade 4.5 ELITE, Full Radius, VULCAN Generator-Compatible Part Number: 7209 recall (Z-1233-06) | Smith & Nephew, Inc. Endoscopy Division | 2006-07-13 |
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 |