FCX — Insufflator, Automatic Carbon-Dioxide For Endoscope Class II
FDA product code FCX covers "Insufflator, Automatic Carbon-Dioxide For Endoscope", a Class II medical device regulated under 21 CFR 876.1500. Submissions are reviewed by the Gastroenterology, Urology panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- FCX
- Device Class
- Class II
- Regulation Number
- 876.1500
- Submission Type
- Review Panel
- GU
- Medical Specialty
- Gastroenterology, Urology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K240847 | ide vision | MedicCO2LON (MedicCO2LON) | October 30, 2024 |
| K230474 | palliare | EVA5 Insufflator | March 24, 2023 |
| K202922 | palliare | END 200 Endoscopic Tubeset | July 8, 2021 |
| K201096 | karl storz endoscopy america | CO2mbiLED | June 23, 2020 |
| K190985 | baronova | BAROnova Insufflation System, BAROnova Accessory Kit | May 14, 2019 |
| K180711 | fujifilm corporation | FUJIFILM Endoscopic CO2 Regulator GW-100 | May 25, 2018 |
| K162332 | nexcore technology | Nexcore GI Insufflator | September 29, 2016 |
| K133976 | fujifilm medical system u.s.a | FUJIFILM ENDOSCOPIC CO2 REGULATOR | September 9, 2014 |
| K132192 | bracco diagnostic | BRACCO DIAGNOSTICS INC. PROTOCO, L TOUCH COLON INSUFFLATOR | February 14, 2014 |
| K123047 | bracco diagnostic | BRACCO DIAGNOSTICS INC. CO2 ENDOSCOPIC INSUFFLATOR IN LINE TUBING SET | August 6, 2013 |
| K113310 | byrne medical | ENDOGATER AVANTAGE CO2 INSUFFLATOR | June 20, 2012 |
| K111648 | bracco diagnostic | BRACCO DIAGNOSTICS, INC. CO2MPACT ENDODCOPIC INSUFFLATOR | November 3, 2011 |
| K090879 | lexion medical | INSUFLOW CO2IONSHIELD | July 23, 2009 |
| K063786 | olympus medical systems corporation | ENDOSCOPIC INSUFFLATION UNIT, MODEL XECR-2 | March 5, 2007 |
| K053008 | e-z-em | E-Z-EM ENDOSCOPIC CO2 REGULATOR | December 27, 2005 |
| K030854 | e-z-em | PROTOCO2L COLON INSUFFLATOR WITH PERFORMANCE IMPROVEMENTS, MODEL 6400 | April 16, 2003 |
| K013219 | e-z-em | PROTOCO2L INSUFFLATOR MODEL 6400 | February 19, 2002 |
| K945970 | xylog | INSUFFLATOR FILTER TUBING SET | December 15, 1994 |
| K930581 | e-z-em | E-Z-FLATE | July 1, 1994 |
| K935059 | phx technologies | INSUFFLATION TUBING SET, PHX500-082 | December 22, 1993 |