ACUFEX T-BAR
FDA 510(k) clearance K925573 · decided 1993-05-05
Clearance details
- K-number
- K925573
- Device name
- ACUFEX T-BAR
- Applicant
- Acufex Microsurgical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1992-11-03
- Decision date
- 1993-05-05
- Days to decision
- 183 days
- Clearance type
- Traditional
- Product code
- HRX
- Device class
- 2
- Regulation number
- 888.1100
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Mansfield, MA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Smith & Nephew T-F1X0 RCG Drill Pac, 2 mm Drill & (2) Sleeves - Product Usage: indicated f recall (Z-2702-2020) | Smith & Nephew, Inc. | 2020-07-24 |