Boehringer Laboratories Suction Intermittor
FDA 510(k) K853095 · Boehringer Laboratories
510(k) numberK853095
Submission
- Device name
- Boehringer Laboratories Suction Intermittor
- Applicant
- Boehringer Laboratories
Norristown, PA, US - Received
- July 23, 1985
- Decision date
- August 23, 1985
- 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 |
|---|---|---|
| K261890 | 52Fr ViSiGi LUX; 52Fr ViSiGi 3D®KNT · Special | 08/14/2026SE |
| K243399 | Boehringer Laboratories Liver RetractorGCJ · Traditional | 07/02/2025SE |
| K234033 | ViSiGi LUX (5332); ViSiGi LUX (5336); ViSiGi LUX (5340)KNT · Traditional | 05/06/2024SE |
| K234145 | ViSiGi 3D Gastric Sizing TubeKNT · Special | 01/26/2024SE |
| K151990 | Tissue Removal SystemGCJ · Traditional | 09/11/2015SE |
| K150781 | Tissue Removal PouchGCJ · Traditional | 06/19/2015SE |
| K130483 | Boehringer Gastric Sizing TubeKNT · Traditional | 03/28/2013SE |
| K061788 | Boehringer Laboratories Suction Pump SystemOMP · Traditional | 07/11/2006SE |
| K060277 | Boehringer Laboratories Suction Pump SystemJCX · Traditional | 03/03/2006SE |
| K020538 | Boehringer Laboratories Pneumatic Ambulatory Compression System 8200 SeriesDWL · Traditional | 05/15/2002SE |
Questions and answers
When was Boehringer Laboratories Suction Intermittor cleared by the FDA?
Boehringer Laboratories Suction Intermittor (K853095) received a 510(k) decision of Substantially Equivalent on August 23, 1985, 31 days after the submission was received.
What is the product code of K853095?
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.