Medcare Yankauer Suction Device
FDA 510(k) K954869 · Medcare Custom Packaging, Inc.
510(k) numberK954869
Submission
- Device name
- Medcare Yankauer Suction Device
- Applicant
- Medcare Custom Packaging, Inc.
East Swanzey, NH, US - Received
- October 24, 1995
- Decision date
- January 19, 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
| 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
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|---|---|---|
| K954442 | Sterile Isotonic Saline & Sterile WaterJOL · Traditional | 12/21/1995SE |
| K952759 | Towel PackKKX · Traditional | 09/29/1995SE |
| K950390 | Urethral Catheterization TrayFCM · Traditional | 05/30/1995SE |
| K943661 | Sterile Physiological Saline/Sterile WaterJOL · Traditional | 04/10/1995SE |
| K951149 | Single Use Instrument TrayLRO · Traditional | 04/06/1995SESK |
| K934732 | Pelvic Exam TrayHHT · Traditional | 12/30/1994SE |
| K942000 | Burn Dressing TrayFRG · Traditional | 05/20/1994SESK |
| K936261 | Catheter Insertion TrayFMI · Traditional | 03/10/1994SESK |
| K922179 | Catheter Insertion TrayFMI · Traditional | 07/02/1993SEKD |
| K901856 | Custom Wound Management Kits and TraysLRO · Traditional | 08/01/1990SESD |
Questions and answers
When was Medcare Yankauer Suction Device cleared by the FDA?
Medcare Yankauer Suction Device (K954869) received a 510(k) decision of Substantially Equivalent on January 19, 1996, 87 days after the submission was received.
What is the product code of K954869?
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.