Suction Instrumentation
FDA 510(k) K972074 · Walter Lorenz Surgical, Inc.
510(k) numberK972074
Submission
- Device name
- Suction Instrumentation
- Applicant
- Walter Lorenz Surgical, Inc.
Jacksonville, FL, US - Received
- June 3, 1997
- Decision date
- July 25, 1997
- 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 |
| 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 |
| K954869 | Medcare Yankauer Suction DeviceGCX · Traditional | Medcare Custom Packaging, Inc. | 01/19/1996SE |
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| K063506 | Lorenz Sternal Closure SystemHRS · Special | 12/18/2006SE |
| K062842 | Twist DrillHBE · Traditional | 12/04/2006SE |
| K061384 | Lorenz Pectus Support Bar, Titanium; Lorenz Pectus Support Bar Stabilizer, TitaniumHRS · Special | 06/06/2006SE |
| K042516 | OtomimixNEA · Traditional | 11/08/2004SE |
| K030425 | Lorenz Resorbable Distraction System or ExpanderJEY · Traditional | 05/14/2004SE |
| K040990 | Modification to Self-Drilling Radiographic MarkersNEU · Special | 05/13/2004SE |
| K040983 | Lorenz Self-Drilling Imf ScrewDZE · Special | 05/05/2004SE |
| K033740 | Lorenz Sternal Closure SystemHWC · Special | 12/15/2003SE |
Questions and answers
When was Suction Instrumentation cleared by the FDA?
Suction Instrumentation (K972074) received a 510(k) decision of Substantially Equivalent on July 25, 1997, 52 days after the submission was received.
What is the product code of K972074?
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.