Suction Connecting Tubing
FDA 510(k) K914601 · Bemis Mfg. Co.
510(k) numberK914601
Submission
- Device name
- Suction Connecting Tubing
- Applicant
- Bemis Mfg. Co.
Sheboygan Falls, WI, US - Received
- October 11, 1991
- Decision date
- February 7, 1992
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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 |
|---|---|---|---|
| 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 |
|---|---|---|
| K020921 | No-Pokes Needle Safety DeviceFMI · Traditional | 07/11/2002SE |
| K965248 | Bemis Two Gallon Sharps ContainerFMI · Traditional | 02/14/1997SE |
| K964858 | Bemis Two Gallon Chemotherapy ContainerMMK · Traditional | 02/11/1997SE |
| K960525 | Bemis One Quart Phlebotomy Container (Part Number 100)MMK · Traditional | 03/28/1996SE |
| K953797 | Sharps Disposal ContainersMMK · Traditional | 11/27/1995SE |
| K950340 | Ight and Eleven Gallon Sharps and Chemotherapy ContainersMMK · Traditional | 06/02/1995SE |
| K941665 | Sharps Disposal Container/PhlebotomyMMK · Traditional | 05/23/1994SE |
| K941664 | Sharp Disposal Containers Wall SafeMMK · Traditional | 05/23/1994SE |
| K931664 | Sharps Disposable ContainersMMK · Traditional | 05/23/1994SE |
| K911576 | Chemotherapy ContainerKPE · Traditional | 07/05/1991SE |
Questions and answers
When was Suction Connecting Tubing cleared by the FDA?
Suction Connecting Tubing (K914601) received a 510(k) decision of Substantially Equivalent on February 7, 1992, 119 days after the submission was received.
What is the product code of K914601?
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.