Contain(Tm)
FDA 510(k) K874505 · Arbor Technologies, Inc.
510(k) numberK874505
Submission
- Device name
- Contain(Tm)
- Applicant
- Arbor Technologies, Inc.
Ann Arbor, MI, US - Received
- November 2, 1987
- Decision date
- May 20, 1988
- 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 |
|---|---|---|
| K960928 | SyringefilterBSN · Traditional | 04/04/1997SE |
| K964283 | AutoprimeFPB · Traditional | 01/22/1997SE |
| K922777 | Pressure Tubing and AccessoriesHIF · Traditional | 03/22/1994SE |
| K902666 | Anesthesia Conduction FilterBSN · Traditional | 04/23/1991SE |
| K895859 | Contain(Tm)GCX · Traditional | 02/07/1991SE |
| K902167 | Contain(Tm) Laser Plume FilterJDY · Traditional | 01/04/1991SE |
| K890844 | Microsept 60/20CAK · Traditional | 06/07/1989SE |
| K864113 | Clyde (TM) Filtration SystemFPB · Traditional | 02/04/1987SE |
| K863162 | Vacu-Guard · Traditional | 08/29/1986SE |
Questions and answers
When was Contain(Tm) cleared by the FDA?
Contain(Tm) (K874505) received a 510(k) decision of Substantially Equivalent on May 20, 1988, 200 days after the submission was received.
What is the product code of K874505?
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.