Panels › Gastroenterology, Urology › Product code FEQ · Class 2
Pump, Air, Non-Manual, For Endoscope
Regulation 876.1500
0510(k)s in 12 months (21 all time)
1recalls in 12 months (5 all time)
5recalls that name a 510(k)
Top companies in FEQ
| Company | 510(k)s | Recalls |
|---|---|---|
| Endochoice, Inc. | 6 | 0 |
| United States Endoscopy Group, Inc. | 6 | 0 |
| Erbe USA, Inc. | 3 | 0 |
| Keymed (Medical & Industrial Equipment), Ltd. | 2 | 0 |
| Olympus America Inc. | 0 | 2 |
| Olympus Corporation of the Americas | 0 | 2 |
| Byrne Medical, Inc. | 1 | 0 |
| Erbe Medical, LLC | 0 | 1 |
| Keymed, Inc. | 1 | 0 |
| STERIS Corporation | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Mar 11, 2022 | K220395 | EndoGator Endoscopy Irrigation Tubing STERIS Corporation | FEQ |
| Aug 1, 2019 | K191559 | AquaShield System CO2, AquaShield System CO2-PENTAX, AquaShield System CO2-FUJIFILM United States Endoscopy Group, Inc. | FEQ |
| Sep 21, 2018 | K182258 | AquaShield System CO2 ; AquaShield System CO2 - PENTAX ; AquaShield System CO2 - Fujifilm United States Endoscopy Group, Inc. | FEQ |
| Jan 5, 2018 | K173650 | AquaShield System CO2- Fujifilm United States Endoscopy Group, Inc. | FEQ |
| Jan 4, 2017 | K163424 | AquaShield System - PENTAX, AquaShield System CO2 - PENTAX, AquaShield System CO2 - FUJINON United State Endoscopy Group, Inc. | FEQ |
| Aug 31, 2016 | K162152 | Erbes CO2 Tubing/Cap Sets Erbe USA, Inc. | FEQ |
| Jun 27, 2016 | K161482 | EndoChoice Water Bottle Cap Irrigation System Endochoice, Inc. | FEQ |
| Feb 24, 2016 | K153588 | EndoChoice Water Bottle Cap System Endochoice, Inc. | FEQ |
| Dec 16, 2015 | K153362 | AquaShield system CO2, AquaShield system-PENTAX United States Endoscopy Group, Inc. | FEQ |
| Jan 20, 2015 | K142155 | ENDOCHOICE WATER BOTTLE CAP SYSTEM Endochoice, Inc. | FEQ |
| Jan 8, 2014 | K133747 | ENDOCHOICE WATER BOTTLE CAP IRRIGATION SYSTEM Endochoice, Inc. | FEQ |
| Dec 17, 2013 | K132340 | ERBEFLO CLEVERCAP HYBRID TUBING/CAP SET FOR PENTAX SCOPES, ERBEFLO CLEVERCAP HYBRID CO2 TUBING/CAP SET FOR OLYMPUS 160/1 Erbe USA, Inc. | FEQ |
| Nov 27, 2012 | K120862 | WATER BOTTLE CAP IRRIGATON SYSTEM Endochoice, Inc. | FEQ |
| Mar 28, 2012 | K120123 | AQUASHIELD CO2 SYSTEM United States Endoscopy Group, Inc. | FEQ |
| Jan 25, 2012 | K112576 | ENDOCHOICE WATER BOTTLE CAP SYSTEM Endochoice, Inc. | FEQ |
| Mar 22, 2011 | K103696 | ERBEFLO CLEVERCAP HYBRID TUBING/CAP SETS FOR OLYMPUS MODELS 160 AND 180 SERIES SCOPES Erbe USA, Inc. | FEQ |
| Sep 13, 2010 | K100899 | OLYMPUS ENDOSCOPIC FLUSHING PUMP, MODEL OPF-2 Keymed (Medical & Industrial Equipment), Ltd. | FEQ |
| Jul 16, 2010 | K101146 | WATER BOTTLE CAP SYSTEM United States Endoscopy Group, Inc. | FEQ |
| Apr 22, 2010 | K100803 | OLYMPUS FLUSHING PUMP OFP MODEL: OFP-1 Keymed, Inc. | FEQ |
| Nov 19, 2009 | K092429 | ENDOGATOR Byrne Medical, Inc. | FEQ |
| May 12, 2000 | K000948 | OLYMPUS ENDOSCOPIC FLUSHING PUMP MODEL OFP-1 Keymed (Medical & Industrial Equipment), Ltd., GB | FEQ |
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