STRYKER STRYKEFLOW SUCTION IRRIGATOR GRAVITY FLOW
FDA 510(k) clearance K963646 · decided 1997-04-16
Clearance details
- K-number
- K963646
- Device name
- STRYKER STRYKEFLOW SUCTION IRRIGATOR GRAVITY FLOW
- Applicant
- Stryker Endoscopy
- Decision
- Substantially Equivalent
- Date received
- 1996-09-12
- Decision date
- 1997-04-16
- Days to decision
- 216 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
- Santa Clara, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| STRYKER PKG., SINGLE SPIKE TUBE SET, Catalog Number 0250070530 recall (Z-2865-2026) | Stryker Corporation | 2026-08-03 |
| STRYKER PKG., STRYKEFLOW SUCTION/IRRIGATOR PS, Catalog Number 0250070540 recall (Z-2866-2026) | Stryker Corporation | 2026-08-03 |