DYONICS VARICOSE VEIN ABLATION BLADE
FDA 510(k) clearance K990723 · decided 1999-10-05
Clearance details
- K-number
- K990723
- Device name
- DYONICS VARICOSE VEIN ABLATION BLADE
- Applicant
- Smith & Nephew, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1999-03-05
- Decision date
- 1999-10-05
- Days to decision
- 214 days
- Clearance type
- Traditional
- 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 |
|---|---|---|
| TriVex 100SV Resector Kit, 4.5 Part Number: 7205876 recall (Z-1226-06) | Smith & Nephew, Inc. Endoscopy Division | 2006-07-13 |
| TriVex 200LV Resector Kit, 5.5 Part Number: 7209271 recall (Z-1227-06) | Smith & Nephew, Inc. Endoscopy Division | 2006-07-13 |
| 4.5 mm TRIVEX System Resector Kit (blade and tubing), 3 per box Part Number: 7209514 recall (Z-1228-06) | Smith & Nephew, Inc. Endoscopy Division | 2006-07-13 |
| 5.5 mm TRIVEX System Resector Kit (blade and tubing), 3 per box Part Number: 7209515 recall (Z-1229-06) | 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 |