Stopcock
FDA 510(k) K896562 · Westmark, Sterile Packing Systems, Inc. (Sps)
510(k) numberK896562
Submission
- Device name
- Stopcock
- Applicant
- Westmark, Sterile Packing Systems, Inc. (Sps)
Grand Rapids, MI, US - Received
- November 17, 1989
- Decision date
- February 6, 1990
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 |
|---|---|---|---|
| K042454 | Stryker Cassette PumpGCX · Traditional | Stryker Endoscopy | 12/09/2004SE |
| 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 |
More from Custom Pack Reliability
| 510(k) | Device | Decision |
|---|---|---|
| K896800 | Irrigation TrayKYZ · Traditional | 05/24/1990SESK |
| K896799 | Paracervical/Pudendal TraysCAZ · Traditional | 04/23/1990SE |
| K896559 | Infant Feeding TubeFPD · Traditional | 03/13/1990SE |
| K896794 | Specimen ContainerLIO · Traditional | 03/01/1990SE |
| K896806 | Catheter Plug/ProtectorKNY · Traditional | 02/26/1990SE |
| K896798 | Tracheostomy TrayBTO · Traditional | 02/22/1990SE |
| K896797 | Suction Catheter KitBSY · Traditional | 02/16/1990SE |
| K896215 | Mercy Hip/Knee PackKKX · Traditional | 02/13/1990SE |
| K896804 | ManifoldGCX · Traditional | 02/08/1990SE |
| K896563 | Tubing ConnectorsGCX · Traditional | 02/06/1990SE |
Questions and answers
When was Stopcock cleared by the FDA?
Stopcock (K896562) received a 510(k) decision of Substantially Equivalent on February 6, 1990, 81 days after the submission was received.
What is the product code of K896562?
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.