PROTOCO2L Colon Insufflator with Performance Improvements, Model 6400
FDA 510(k) K030854 · E-Z-Em, Inc.
510(k) numberK030854
Submission
- Device name
- PROTOCO2L Colon Insufflator with Performance Improvements, Model 6400
- Applicant
- E-Z-Em, Inc.
Westbury, NY, US - Received
- March 18, 2003
- Decision date
- April 16, 2003
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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
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| K230474 | EVA5 InsufflatorFCX · Special | Palliare , Ltd. | 03/24/2023SE |
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| 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 |
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| 510(k) | Device | Decision |
|---|---|---|
| K071378 | Modification to Empower Ct/Cta Injector System, Models 9800/9900 Product SeriesJAK · Special | 06/13/2007SE |
| K062449 | Empowermr Injector System, Model 9730IZQ · Abbreviated | 04/13/2007SE |
| K063029 | Empower Ct/Cta Injector System, Model 9800/9900JAK · Special | 11/02/2006SE |
| K053008 | E-Z-Em Endoscopic CO2 RegulatorFCX · Abbreviated | 12/27/2005SE |
| K041178 | Empower Transfer Set, (Cat. No. 7725)FPK · Traditional | 07/16/2004SE |
| K031571 | Empowercta Injector System, Models 9930 & 9910 & 9825IZQ · Special | 06/19/2003SE |
| K013219 | PROTOCO2L Insufflator Model 6400FCX · Abbreviated | 02/19/2002SE |
| K011160 | E-Z Em Percupump 2001 CT InjectorJAK · Special | 05/16/2001SE |
| K974621 | Percupump II with EdaDSB · Traditional | 01/27/1998SE |
| K961845 | Percupump II with EdaDSB · Traditional | 01/23/1997SE |
Questions and answers
When was PROTOCO2L Colon Insufflator with Performance Improvements, Model 6400 cleared by the FDA?
PROTOCO2L Colon Insufflator with Performance Improvements, Model 6400 (K030854) received a 510(k) decision of Substantially Equivalent on April 16, 2003, 29 days after the submission was received.
What is the product code of K030854?
The FDA product code is FCX – Insufflator, Automatic Carbon-Dioxide For Endoscope, a Class II (moderate risk) device regulated under 21 CFR 876.1500.