Medi-Vac Flexi-Clear Suction Handle
FDA 510(k) K964127 · Allegiance Healthcare Corp.
510(k) numberK964127
Submission
- Device name
- Medi-Vac Flexi-Clear Suction Handle
- Applicant
- Allegiance Healthcare Corp.
Mcgraw Park, IL, US - Received
- October 15, 1996
- Decision date
- December 31, 1996
- 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
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|---|---|---|---|
| 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 |
| 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 Medi-Vac Flexi-Clear Suction Handle cleared by the FDA?
Medi-Vac Flexi-Clear Suction Handle (K964127) received a 510(k) decision of Substantially Equivalent on December 31, 1996, 77 days after the submission was received.
What is the product code of K964127?
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.