COMMAND 2 MICOELECTRIC SURGICAL SYSTEM
FDA 510(k) clearance K961970 · decided 1996-07-26
Clearance details
- K-number
- K961970
- Device name
- COMMAND 2 MICOELECTRIC SURGICAL SYSTEM
- Applicant
- Stryker Corp.
- Decision
- Substantially Equivalent
- Date received
- 1996-05-20
- Decision date
- 1996-07-26
- Days to decision
- 67 days
- Clearance type
- Traditional
- Product code
- HWE
- Device class
- 1
- Regulation number
- 878.4820
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Kalamazoo, MI, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Stryker Bur Guard REF 2296-301, Stryker Instruments, Kalamazoo, MI (USA) The Impaction Bur recall (Z-2420-2010) | Stryker Instruments Div. of Stryker Corporation | 2010-09-13 |
| Stryker Impaction Bur Guard REF 2296-301, 2296-300, 0260-901-300, & 5400-300; Stryker Inst recall (Z-1052-2009) | Stryker Instruments Div. of Stryker Corporation | 2009-03-30 |
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| VITAGEL RT3 SUTGICAL HEMOSTAT (P050044/S033) | Stryker Corp. | 2017-03-02 |
| VITAGEL RT3 SURGICAL HEMOSTAT (P050044/S032) | Stryker Corp. | 2015-07-16 |
| VITAGEL SURGICAL HEMOSTAT (RT3) (P050044/S031) | Stryker Corp. | 2015-04-14 |
| VITAGEL SURGICAL HEMOSTAT (RT3) (P050044/S030) | Stryker Corp. | 2015-04-13 |
| VITAGEL RT3 SURGICAL HEMOSTAT (P050044/S029) | Stryker Corp. | 2014-12-12 |
| VITAGEL RT3 DELIVERY SYSTEM (P050044/S028) | Stryker Corp. | 2014-06-05 |
| VITAGEL SURGICAL HEMOSTAT (VITAGEL) (P050044/S026) | Stryker Corp. | 2014-02-11 |
| RT3 SURGICAL HEMOSTAT (P050044/S027) | Stryker Corp. | 2014-01-27 |