STRYKER CASSETTE PUMP
FDA 510(k) clearance K042454 · decided 2004-12-09
Clearance details
- K-number
- K042454
- Device name
- STRYKER CASSETTE PUMP
- Applicant
- Stryker Endoscopy
- Decision
- Substantially Equivalent
- Date received
- 2004-09-10
- Decision date
- 2004-12-09
- Days to decision
- 90 days
- Clearance type
- Traditional
- Product code
- GCX
- Device class
- 2
- Regulation number
- 880.6740
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- San Jose, CA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| CIRCON SURGIFLEX WAVE TSUNAMI SUCTION-IRRIGATION SYSTEM (K992126) | Circon Corp. | 1999-08-03 |
| SUCTION INSTRUMENTATION (K972074) | Walter Lorenz Surgical, Inc. | 1997-07-25 |
| CHASE SUCKER (K971022) | Chase Medical, Inc. | 1997-04-17 |
| MEDI-VAC FLEXI-CLEAR SUCTION HANDLE (K964127) | Allegiance Healthcare Corp. | 1996-12-31 |
| CURITY THORACENTESIS TRAY (K964519) | Kendall Healthcare Products Co. Div.Of Tyco Health | 1996-12-20 |
| STRYKER SUCTION REGULATOR (K963648) | Stryker Endoscopy | 1996-11-26 |
| RENTON SUCTION DEVICE U.S. PATENT*4,767,404 (K962920) | R&S Surgical, LLC | 1996-10-21 |
| MEDCARE SUCTION CONNECTING TUBING (K961880) | Medcare Medical Group, Inc. | 1996-07-19 |
| CPR YANKAUER (K960223) | Custom Pack Reliability | 1996-03-28 |
| MEDCARE YANKAUER SUCTION DEVICE (K954869) | Medcare Custom Packaging, Inc. | 1996-01-19 |
| STRYKER STRYKEFLOW SUCTION IRRIGATOR (MODIFICATION) (K954726) | Stryker Endoscopy | 1995-11-29 |
| SUCTION TIP CLEANER CUP (K952219) | Moore/Gobel | 1995-11-15 |
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| STRYKER AHTO TUBE SET PACKAGING, Catalog Number 0250070600 recall (Z-2862-2026) | Stryker Corporation | 2026-08-03 |
| STRYKER AHTO TUBE SET WITH TIP PACKAGING, Catalog Number 0250070620 recall (Z-2863-2026) | Stryker Corporation | 2026-08-03 |
| STRYKER AHTO DUAL SPIKE TUBE SET PACKAGING, Catalog Number 0250070640 recall (Z-2864-2026) | Stryker Corporation | 2026-08-03 |
| StrykeFlow II Disposable Suction/Irrigator; AHTO Tube Set; Model Numbers: 250-070-500, 250 recall (Z-0279-06) | Stryker Endoscopy | 2005-12-14 |