Company ยท US
Endochoice, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 2010 to 2016. Name variants (Inc, Corp, punctuation) are merged.
27510(k) clearances (0 in 12 months)
1recalls (0 in 12 months)
1recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| FEQ | Pump, Air, Non-Manual, For Endoscope | 6 |
| OCX | Endoscopic Irrigation/Suction System | 4 |
| FDF | Colonoscope And Accessories, Flexible/Rigid | 3 |
| FBK | Endoscopic Injection Needle, Gastroenterology-Urology | 2 |
| FDI | Snare, Flexible | 2 |
| FDS | Gastroscope And Accessories, Flexible/Rigid | 2 |
| FGE | Stents, Drains And Dilators For The Biliary Ducts | 2 |
| ESW | Prosthesis, Esophageal | 1 |
| JCT | Prosthesis, Tracheal, Expandable | 1 |
| KGE | Forceps, Biopsy, Electric | 1 |
| MND | Ligator, Esophageal | 1 |
| OCZ | Endoscopic Grasping/Cutting Instrument, Non-Powered | 1 |
| ODC | Endoscope Channel Accessory | 1 |
| PEA | Endoscope, Accessories, Image Post-Processing For Color Enhancement | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Aug 1, 2016 | K160275 | Fuse Endoscopic System with FuseBox Processor Endochoice, Inc. | PEA |
| Jun 27, 2016 | K161482 | EndoChoice Water Bottle Cap Irrigation System Endochoice, Inc. | FEQ |
| May 26, 2016 | K161167 | Seal Single-Use Biopsy Valve Endochoice, Inc. | OCX |
| May 19, 2016 | K160403 | SmartStart Air/Water and Suction Valves Endochoice, Inc. | ODC |
| Feb 24, 2016 | K153588 | EndoChoice Water Bottle Cap System Endochoice, Inc. | FEQ |
| Feb 8, 2016 | K151475 | EndoChoice Select Injection Needle Endochoice, Inc. | FBK |
| Dec 10, 2015 | K152182 | Fuse Gastroscopy System Endochoice, Inc. | FDS |
| Nov 3, 2015 | K152580 | rescuenet Endochoice, Inc. | FDI |
| Jan 20, 2015 | K142155 | ENDOCHOICE WATER BOTTLE CAP SYSTEM Endochoice, Inc. | FEQ |
| Oct 17, 2014 | K140472 | BONASTENT TRACHEAL / BRONCHIAL Endochoice, Inc., CA | JCT |
| Sep 30, 2014 | K141598 | FUSE COLONOSCOPY SYSTEM Endochoice, Inc., IL | FDF |
| Jun 16, 2014 | K140760 | BONASTENT BILIARY Endochoice, Inc., CA | FGE |
| Mar 19, 2014 | K133734 | SEAL SINGLE-USE BIOPSY VALVE Endochoice, Inc. | OCX |
| Feb 6, 2014 | K132839 | FUSE 1C COLONOSCOPY SYSTEM Endochoice, Inc. | FDF |
| Jan 17, 2014 | K132065 | INJECTION NEEDLE Endochoice, Inc. | FBK |
| Jan 8, 2014 | K133747 | ENDOCHOICE WATER BOTTLE CAP IRRIGATION SYSTEM Endochoice, Inc. | FEQ |
| Dec 20, 2013 | K132776 | SEAL BIOPSY VALVE - REUSABLE Endochoice, Inc. | OCX |
| Oct 15, 2013 | K131991 | ENDOCHOICE HOT BIOPSY FORCEPS Endochoice, Inc. | KGE |
| Oct 10, 2013 | K131422 | PEERSCOPE SYSTEM Endochoice, Inc., IL | FDS |
| Aug 23, 2013 | K132535 | AUTOBAND LIGATOR Endochoice, Inc. | MND |
| Jan 10, 2013 | K123223 | EC SINGLE USE, POLYPECTOMY SNARE Endochoice, Inc. | FDI |
| Nov 27, 2012 | K120862 | WATER BOTTLE CAP IRRIGATON SYSTEM Endochoice, Inc. | FEQ |
| Jan 25, 2012 | K112576 | ENDOCHOICE WATER BOTTLE CAP SYSTEM Endochoice, Inc. | FEQ |
| Jul 28, 2011 | K111821 | BIOPSY VALVE Endochoice, Inc. | OCX |
| Aug 5, 2010 | K101298 | ENDOCHOICE GRASPING INSULATED AND ALIGATOR JAW FORCEPS MODEL AMHGFA, ENDOCHOICE GRASPING INSULATED AND RAT TOOTH FORCEPS Endochoice, Inc. | OCZ |
| Mar 24, 2010 | K093003 | BONASTENT BILIARY Endochoice, Inc. | FGE |
| Feb 22, 2010 | K092144 | BONASTENT ESOPHAGEAL, MODELS BE AND BER, BONASTENT ESOPHAGEAL U.E.S. FLANGE AND FLARE, MODELS BEFG AND BEFR Endochoice, Inc. | ESW |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 27, 2016 | EndoChoice, Inc. Fuse 1C Colonoscope Terminated |
FDF | K141598 |