Stryker Cassette Pump
FDA 510(k) K042454 · Stryker Endoscopy
510(k) numberK042454
Submission
- Device name
- Stryker Cassette Pump
- Applicant
- Stryker Endoscopy
San Jose, CA, US - Received
- September 10, 2004
- Decision date
- December 9, 2004
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- GCX – Apparatus, Suction, Operating-Room, Wall Vacuum Powered
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.6740
- Specialty
- General Hospital
Other 510(k)s with product code GCX
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K992126 | Circon Surgiflex Wave Tsunami Suction-Irrigation SystemGCX · Traditional | Circon Corp. | 08/03/1999SE |
| K972074 | Suction InstrumentationGCX · Traditional | Walter Lorenz Surgical, Inc. | 07/25/1997SE |
| K971022 | Chase SuckerGCX · Traditional | Chase Medical, Inc. | 04/17/1997SE |
| K964127 | Medi-Vac Flexi-Clear Suction HandleGCX · Traditional | Allegiance Healthcare Corp. | 12/31/1996SE |
| K964519 | Curity Thoracentesis TrayGCX · Traditional | Kendall Healthcare Products Co. Div.Of Tyco Health | 12/20/1996SE |
| K963648 | Stryker Suction RegulatorGCX · Traditional | Stryker Endoscopy | 11/26/1996SE |
| K962920 | Renton Suction Device U.S. PATENT*4,767,404GCX · Traditional | R&S Surgical, LLC | 10/21/1996SE |
| K961880 | Medcare Suction Connecting TubingGCX · Traditional | Medcare Medical Group, Inc. | 07/19/1996SE |
| K960223 | CPR YankauerGCX · Traditional | Custom Pack Reliability | 03/28/1996SE |
| K954869 | Medcare Yankauer Suction DeviceGCX · Traditional | Medcare Custom Packaging, Inc. | 01/19/1996SE |
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Questions and answers
When was Stryker Cassette Pump cleared by the FDA?
Stryker Cassette Pump (K042454) received a 510(k) decision of Substantially Equivalent on December 9, 2004, 90 days after the submission was received.
What is the product code of K042454?
The FDA product code is GCX – Apparatus, Suction, Operating-Room, Wall Vacuum Powered, a Class II (moderate risk) device regulated under 21 CFR 880.6740.