EndoChoice Water Bottle Cap System
FDA 510(k) K153588 · Endochoice, Inc.
510(k) numberK153588
Submission
- Device name
- EndoChoice Water Bottle Cap System
- Applicant
- Endochoice, Inc.
Alpharetta, GA, US - Received
- December 16, 2015
- Decision date
- February 24, 2016
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- FEQ – Pump, Air, Non-Manual, For Endoscope
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.1500
- Specialty
- Gastroenterology, Urology
Other 510(k)s with product code FEQ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K220395 | EndoGator Endoscopy Irrigation TubingFEQ · Special | STERIS Corporation | 03/11/2022SE |
| K191559 | AquaShield System CO2, AquaShield System CO2-PENTAX, AquaShield System CO2-FUJIFILMFEQ · Special | United States Endoscopy Group, Inc. | 08/01/2019SE |
| K182258 | AquaShield System CO2 ; AquaShield System CO2 - PENTAX ; AquaShield System CO2 - FujifilmFEQ · Special | United States Endoscopy Group, Inc. | 09/21/2018SE |
| K173650 | AquaShield System CO2- FujifilmFEQ · Special | United States Endoscopy Group, Inc. | 01/05/2018SE |
| K163424 | AquaShield System - PENTAX, AquaShield System CO2 - PENTAX, AquaShield System CO2 -…FEQ · Special | United State Endoscopy Group, Inc. | 01/04/2017SE |
| K162152 | Erbes CO2 Tubing/Cap SetsFEQ · Special | Erbe USA, Inc. | 08/31/2016SE |
| K161482 | EndoChoice Water Bottle Cap Irrigation SystemFEQ · Special | Endochoice, Inc. | 06/27/2016SE |
| K153362 | AquaShield system CO2, AquaShield system-PENTAXFEQ · Special | United States Endoscopy Group, Inc. | 12/16/2015SE |
| K142155 | Endochoice Water Bottle Cap SystemFEQ · Traditional | Endochoice, Inc. | 01/20/2015SE |
| K133747 | Endochoice Water Bottle Cap Irrigation SystemFEQ · Special | Endochoice, Inc. | 01/08/2014SE |
More from Endochoice, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K160275 | Fuse Endoscopic System with FuseBox ProcessorPEA · Traditional | 08/01/2016SE |
| K161482 | EndoChoice Water Bottle Cap Irrigation SystemFEQ · Special | 06/27/2016SE |
| K161167 | Seal Single-Use Biopsy ValveOCX · Special | 05/26/2016SE |
| K160403 | SmartStart Air/Water and Suction ValvesODC · Traditional | 05/19/2016SE |
| K151475 | EndoChoice Select Injection NeedleFBK · Traditional | 02/08/2016SE |
| K152182 | Fuse Gastroscopy SystemFDS · Special | 12/10/2015SE |
| K152580 | rescuenetFDI · Traditional | 11/03/2015SE |
| K142155 | Endochoice Water Bottle Cap SystemFEQ · Traditional | 01/20/2015SE |
| K140472 | Bonastent Tracheal / BronchialJCT · Traditional | 10/17/2014SE |
| K141598 | Fuse Colonoscopy SystemFDF · Special | 09/30/2014SE |
Questions and answers
When was EndoChoice Water Bottle Cap System cleared by the FDA?
EndoChoice Water Bottle Cap System (K153588) received a 510(k) decision of Substantially Equivalent on February 24, 2016, 70 days after the submission was received.
What is the product code of K153588?
The FDA product code is FEQ – Pump, Air, Non-Manual, For Endoscope, a Class II (moderate risk) device regulated under 21 CFR 876.1500.