AquaShield System CO2 ; AquaShield System CO2 - PENTAX ; AquaShield System CO2 - Fujifilm
FDA 510(k) K182258 · United States Endoscopy Group, Inc.
510(k) numberK182258
Submission
- Device name
- AquaShield System CO2 ; AquaShield System CO2 - PENTAX ; AquaShield System CO2 - Fujifilm
- Applicant
- United States Endoscopy Group, Inc.
Mentor, OH, US - Received
- August 21, 2018
- Decision date
- September 21, 2018
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) statement 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 |
| 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 |
| K153588 | EndoChoice Water Bottle Cap SystemFEQ · Special | Endochoice, Inc. | 02/24/2016SE |
| 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.
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| K192265 | gi-4000 Electrosurgical GeneratorGEI · Traditional | 05/21/2020SE |
| K200745 | Lariat, Hot/Cold SnareFDI · Special | 04/21/2020SE |
| K192059 | Bio Guard Air/Water & Suction ValvesODC · Special | 09/17/2019SE |
| K191559 | AquaShield System CO2, AquaShield System CO2-PENTAX, AquaShield System CO2-FUJIFILMFEQ · Special | 08/01/2019SE |
| K182909 | Roth Net Retriever Product LineFDI · Special | 11/21/2018SE |
| K173650 | AquaShield System CO2- FujifilmFEQ · Special | 01/05/2018SE |
| K172805 | gi-4000 Electrosurgical GeneratorGEI · Special | 10/23/2017SE |
| K163495 | AdvanCE capsule endoscope delivery deviceNEZ · Traditional | 03/10/2017SE |
| K163492 | Oracle EUS Balloon; Oracle EUS latex balloon - Olympus Radial; Oracle EUS latex balloon…FDF · Special | 01/06/2017SE |
| K153362 | AquaShield system CO2, AquaShield system-PENTAXFEQ · Special | 12/16/2015SE |
Questions and answers
When was AquaShield System CO2 ; AquaShield System CO2 - PENTAX ; AquaShield System CO2 - Fujifilm cleared by the FDA?
AquaShield System CO2 ; AquaShield System CO2 - PENTAX ; AquaShield System CO2 - Fujifilm (K182258) received a 510(k) decision of Substantially Equivalent on September 21, 2018, 31 days after the submission was received.
What is the product code of K182258?
The FDA product code is FEQ – Pump, Air, Non-Manual, For Endoscope, a Class II (moderate risk) device regulated under 21 CFR 876.1500.