Pump, Air, Non-Manual, For Endoscope
FDA product code FEQ · Class II (moderate risk) · 21 CFR 876.1500 · Gastroenterology, Urology
21510(k) clearances
0PMA approvals
5recalls
Manufacturers
510(k) clearances
| 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 |
| 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 |
| K132340 | Erbeflo Clevercap Hybrid Tubing/Cap Set for Pentax Scopes, Erbeflo Clevercap Hybrid CO2…FEQ · Traditional | Erbe USA, Inc. | 12/17/2013SE |
| K120862 | Water Bottle Cap Irrigaton SystemFEQ · Traditional | Endochoice, Inc. | 11/27/2012SE |
| K120123 | Aquashield CO2 SystemFEQ · Traditional | United States Endoscopy Group, Inc. | 03/28/2012SE |
| K112576 | Endochoice Water Bottle Cap SystemFEQ · Traditional | Endochoice, Inc. | 01/25/2012SE |
| K103696 | Erbeflo Clevercap Hybrid Tubing/Cap Sets for Olympus Models 160 and 180 Series ScopesFEQ · Traditional | Erbe USA, Inc. | 03/22/2011SE |
| K100899 | Olympus Endoscopic Flushing Pump, Model OPF-2FEQ · Traditional | Keymed (Medical & Industrial Equipment), Ltd. | 09/13/2010SE |
| K101146 | Water Bottle Cap SystemFEQ · Traditional | United States Endoscopy Group, Inc. | 07/16/2010SE |
| K100803 | Olympus Flushing Pump Ofp Model: OFP-1FEQ · Special | Keymed, Inc. | 04/22/2010SE |
| K092429 | EndogatorFEQ · Traditional | Byrne Medical, Inc. | 11/19/2009SE |
| K000948 | Olympus Endoscopic Flushing Pump Model OFP-1FEQ · Traditional | Keymed (Medical & Industrial Equipment), Ltd. | 05/12/2000SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-2062-2026 Class II | ERBEFLO CleverCap CO2: Hybrid CO2 Tubing/Cap Set for Olympus Scopes & CO2 Sources, REF:…Devices providing sterile water/CO2/air to endoscopes were manufactured with a distal irrigation segment… | Erbe Medical, LLC | 03/31/2026Open, Classified |
| Z-0229-2025 Class II | Olympus Endoscopic Flushing Pump, Model/Catalog Number: OFP-2 (K10001141)During product testing, Olympus identified an intermittent loss of function of the OFP-2 Flushing Pump… | Olympus Corporation of the Americas | 08/23/2024Open, Classified |
| Z-0113-2016 Class II | MAJ-1606 Instrument Channel Adaptor; a single use adapter which enables a connection…small puncture marks in a sterile package for an accessory to an Olympus device | Olympus Corporation of the Americas | 09/11/2015Terminated |
| Z-0329-2014 Class II | Olympus Endoscopic Flushing Pump, Model OPF-2. Facilitates washing of tissues to remove…There is a possibility that the pump head was not shipped in the locked position. If the pump head is in an… | Olympus America Inc. | 05/20/2013Terminated |
| Z-0806-2012 | Olympus OFP Flushing Pump irrigation tubing The Olympus OFP Flushing Pump is a…Water may leak from the irrigation tubing used on the Olympus Flushing Pump | Olympus America Inc. | 12/12/2011Terminated |