ANSPACH SHIELDED ATTACHMENT
FDA 510(k) clearance K974025 · decided 1998-07-06
Clearance details
- K-number
- K974025
- Device name
- ANSPACH SHIELDED ATTACHMENT
- Applicant
- The Anspach Effort, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1997-10-23
- Decision date
- 1998-07-06
- Days to decision
- 256 days
- Clearance type
- Traditional
- Product code
- GFF
- Device class
- 1
- Regulation number
- 878.4820
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Palm Beach Gardens, FL, US
- Third-party review
- No
- Expedited review
- No
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| BURS FOR MICRO SURGICAL DRILL SYSTEM (K853658) | Acumed Instruments Corp. | 1985-09-24 |
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| AnspacSingle use Sterile bone cutting burs.h REF: S-1504TD Twist Drill for 1.5mm x 4mm scr recall (Z-0829-2014) | The Anspach Effort, Inc. | 2014-01-27 |
| Anspach REF: TURQ-434-4 Twist Drill for 1.5mm x 4mm screw. Rx only Single use Sterile bone recall (Z-0830-2014) | The Anspach Effort, Inc. | 2014-01-27 |
| .***ANSPACH***Sterile. REF SHD-4820DS***QTY: 1, 4.8 mm x 2mm Twist Drill with Depth Stop. recall (Z-2077-2012) | The Anspach Effort, Inc. | 2012-07-25 |
| Cutting Burr labeled in part:"***S-1504TD QTY:1***Twist Drill for 1.5 mm x 4 mm Screw. Use recall (Z-3202-2011) | The Anspach Effort, Inc. | 2011-09-14 |
| Cutting Burr labeled in part:"***TURQ-434-4 QTY:1***Twist Drill for 1.5 mm x 4 mm Screw. U recall (Z-3203-2011) | The Anspach Effort, Inc. | 2011-09-14 |