STRYKER TRAUMA TRAY
FDA 510(k) clearance K894470 · decided 1989-08-18
Clearance details
- K-number
- K894470
- Device name
- STRYKER TRAUMA TRAY
- Applicant
- Stryker Corp.
- Decision
- Substantially Equivalent
- Date received
- 1989-07-18
- Decision date
- 1989-08-18
- Days to decision
- 31 days
- Clearance type
- Traditional
- Product code
- KYZ
- Device class
- 1
- Regulation number
- 880.6960
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Rockville, MD, US
- Third-party review
- No
- Expedited review
- No
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| RMI DUAL FLUID IRRIGATING SYRINGE (K964833) | Research Medical, Inc. | 1997-02-19 |
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| REDI NURSE SYSTEM (RNS) PRE-FILLED 60CC IRRIGATION SYRINGE W/STERILE SODIUM CHLORIDE SOLUTION (K952406) | Contour Fabricators of Florida, Inc. | 1995-08-07 |
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Recalls involving this device
No recalls on record reference this clearance.
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 |