Pneumo Drain T.M. Recorder #PD-800
FDA 510(k) K821160 · Sugen Industries, Inc.
510(k) numberK821160
Submission
- Device name
- Pneumo Drain T.M. Recorder #PD-800
- Applicant
- Sugen Industries, Inc.
Walker, MI, US - Received
- April 22, 1982
- Decision date
- May 27, 1982
- 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 |
Questions and answers
When was Pneumo Drain T.M. Recorder #PD-800 cleared by the FDA?
Pneumo Drain T.M. Recorder #PD-800 (K821160) received a 510(k) decision of Substantially Equivalent on May 27, 1982, 35 days after the submission was received.
What is the product code of K821160?
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.