Pleural Drainage Reservoir
FDA 510(k) K820765 · Innovative Surgical Products, Inc.
510(k) numberK820765
Submission
- Device name
- Pleural Drainage Reservoir
- Applicant
- Innovative Surgical Products, Inc.
Walker, MI, US - Received
- March 22, 1982
- Decision date
- April 15, 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 |
More from Custom Pack Reliability
| 510(k) | Device | Decision |
|---|---|---|
| K843041 | Heslin Dispos. Tubing SetHQE · Traditional | 11/21/1984SE |
| K840695 | Phacoemulsification KitsHQC · Traditional | 05/22/1984SE |
| K840693 | Disposable Scleral Globe PlugLXP · Traditional | 05/22/1984SE |
| K840694 | Lens Insertion GlideKYB · Traditional | 05/09/1984SE |
| K841072 | Irrigation, Aspiration Tubing SetsHQC · Traditional | 03/29/1984SE |
| K832235 | Disposable Vitrectomy HandpieceHQE · Traditional | 09/29/1983SE |
| K821496 | Disposable Irriga/Aspir. SystemKDH · Traditional | 06/22/1982SE |
| K820680 | Disposable Tubing SetsKYG · Traditional | 04/09/1982SE |
| K802973 | Ispvac TMGCY · Traditional | 12/19/1980SE |
| K801350 | Acuvac(Tm) Suction Reservoir 400CC andGCY · Traditional | 07/14/1980SE |
Questions and answers
When was Pleural Drainage Reservoir cleared by the FDA?
Pleural Drainage Reservoir (K820765) received a 510(k) decision of Substantially Equivalent on April 15, 1982, 24 days after the submission was received.
What is the product code of K820765?
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.