Endogater Avantage CO2 Insufflator
FDA 510(k) K113310 · Byrne Medical, Inc.
510(k) numberK113310
Submission
- Device name
- Endogater Avantage CO2 Insufflator
- Applicant
- Byrne Medical, Inc.
Minneapolis, MN, US - Received
- November 8, 2011
- Decision date
- June 20, 2012
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- FCX – Insufflator, Automatic Carbon-Dioxide For Endoscope
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.1500
- Specialty
- Gastroenterology, Urology
Other 510(k)s with product code FCX
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K262152 | VS-370CF, VS-370CTFCX · Traditional | VISION MEDICAL Co., Ltd. | 07/24/2026SE |
| K240847 | MedicCO2LON (MedicCO2LON)FCX · Traditional | Ide Vision, Ltd. | 10/30/2024SE |
| K230474 | EVA5 InsufflatorFCX · Special | Palliare , Ltd. | 03/24/2023SE |
| K202922 | END 200 Endoscopic TubesetFCX · Traditional | Palliare , Ltd. | 07/08/2021SE |
| K201096 | CO2mbiLEDFCX · Traditional | Karl Storz Endoscopy America, Inc. | 06/23/2020SE |
| K190985 | BAROnova Insufflation System, BAROnova Accessory KitFCX · Traditional | Baronova, Inc. | 05/14/2019SESK |
| K180711 | FUJIFILM Endoscopic CO2 Regulator GW-100FCX · Special | Fujifilm Corporation | 05/25/2018SE |
| K162332 | Nexcore GI InsufflatorFCX · Traditional | Nexcore Technology, LLC | 09/29/2016SE |
| K133976 | Fujifilm Endoscopic CO2 RegulatorFCX · Traditional | Fujifilm Medical System U.S.A., Inc. | 09/09/2014SE |
| K132192 | Bracco Diagnostics Inc. Protoco, L Touch Colon InsufflatorFCX · Traditional | Bracco Diagnostic, Inc. | 02/14/2014SE |
More from Bracco Diagnostic, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K113119 | Endogator Advantage Irrigation PumpOCX · Traditional | 04/27/2012SE |
| K110088 | Defendo Y-Opsy IrrigatorODC · Traditional | 06/10/2011SE |
| K102855 | Universal Irrigation Solution HybridOCX · Traditional | 11/19/2010SE |
| K102581 | Defendo Disposable Suction Valve Model 100305ODC · Traditional | 11/08/2010SE |
| K102409 | Defendo Disposable Air/Water Valve Model 100304ODC · Traditional | 11/04/2010SE |
| K093665 | Endo SmartcapFAJ · Traditional | 12/15/2009SE |
| K092090 | Erbelift Hand Pump and Flexible ProbeFBK · Traditional | 11/30/2009SE |
| K092429 | EndogatorFEQ · Traditional | 11/19/2009SE |
| K090851 | Defendo (TM) Biopsy Valve for Olympus(R) and Fujinon(R) Endoscopes, Model 100301…ODC · Traditional | 07/02/2009SE |
| K060962 | Endogator Endoscopy Irrigation Pump, Model EGP-100OCX · Traditional | 04/19/2006SE |
Questions and answers
When was Endogater Avantage CO2 Insufflator cleared by the FDA?
Endogater Avantage CO2 Insufflator (K113310) received a 510(k) decision of Substantially Equivalent on June 20, 2012, 225 days after the submission was received.
What is the product code of K113310?
The FDA product code is FCX – Insufflator, Automatic Carbon-Dioxide For Endoscope, a Class II (moderate risk) device regulated under 21 CFR 876.1500.