Product code FEQ
- Device name
- Pump, Air, Non-Manual, For Endoscope
- Medical specialty
- Gastroenterology, Urology
- Device class
- 2
- Regulation number
- 876.1500
- Review panel
- GU
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K220395 | EndoGator Endoscopy Irrigation Tubing | STERIS Corporation | 2022-03-11 |
| K191559 | AquaShield System CO2, AquaShield System CO2-PENTAX, AquaShield System CO2-FUJIFILM | United States Endoscopy Group, Inc. | 2019-08-01 |
| K182258 | AquaShield System CO2 ; AquaShield System CO2 - PENTAX ; AquaShield System CO2 - Fujifilm | United States Endoscopy Group, Inc. | 2018-09-21 |
| K173650 | AquaShield System CO2- Fujifilm | United States Endoscopy Group, Inc. | 2018-01-05 |
| K163424 | AquaShield System - PENTAX, AquaShield System CO2 - PENTAX, AquaShield System CO2 - FUJINON | United State Endoscopy Group, Inc. | 2017-01-04 |
| K162152 | Erbe’s CO2 Tubing/Cap Sets | Erbe USA, Inc. | 2016-08-31 |
| K161482 | EndoChoice Water Bottle Cap Irrigation System | Endochoice, Inc. | 2016-06-27 |
| K153588 | EndoChoice Water Bottle Cap System | Endochoice, Inc. | 2016-02-24 |
| K153362 | AquaShield system CO2, AquaShield system-PENTAX | United States Endoscopy Group, Inc. | 2015-12-16 |
| K142155 | ENDOCHOICE WATER BOTTLE CAP SYSTEM | Endochoice, Inc. | 2015-01-20 |
| K133747 | ENDOCHOICE WATER BOTTLE CAP IRRIGATION SYSTEM | Endochoice, Inc. | 2014-01-08 |
| K132340 | ERBEFLO CLEVERCAP HYBRID TUBING/CAP SET FOR PENTAX SCOPES, ERBEFLO CLEVERCAP HYBRID CO2 TUBING/CAP SET FOR OLYMPUS 160/1 | Erbe USA, Inc. | 2013-12-17 |
| K120862 | WATER BOTTLE CAP IRRIGATON SYSTEM | Endochoice, Inc. | 2012-11-27 |
| K120123 | AQUASHIELD CO2 SYSTEM | United States Endoscopy Group, Inc. | 2012-03-28 |
| K112576 | ENDOCHOICE WATER BOTTLE CAP SYSTEM | Endochoice, Inc. | 2012-01-25 |
| K103696 | ERBEFLO CLEVERCAP HYBRID TUBING/CAP SETS FOR OLYMPUS MODELS 160 AND 180 SERIES SCOPES | Erbe USA, Inc. | 2011-03-22 |
| K100899 | OLYMPUS ENDOSCOPIC FLUSHING PUMP, MODEL OPF-2 | Keymed (Medical & Industrial Equipment), Ltd. | 2010-09-13 |
| K101146 | WATER BOTTLE CAP SYSTEM | United States Endoscopy Group, Inc. | 2010-07-16 |
| K100803 | OLYMPUS FLUSHING PUMP OFP MODEL: OFP-1 | Keymed, Inc. | 2010-04-22 |
| K092429 | ENDOGATOR | Byrne Medical, Inc. | 2009-11-19 |
| K000948 | OLYMPUS ENDOSCOPIC FLUSHING PUMP MODEL OFP-1 | Keymed (Medical & Industrial Equipment), Ltd. | 2000-05-12 |
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| 00191506038885 | Hydra | BOSTON SCIENTIFIC CORPORATION | 2024-10-07 |
| M710TCW101200 | Bayou™ troCarWash System Disposable Kit | BIOTEX, INC. | 2024-01-31 |
| M710TCWC0 | Bayou™ troCarWash System Controller | BIOTEX, INC. | 2024-01-22 |
| M71003810000 | Bayou™ troCarWash System Disposable Kit | BIOTEX, INC. | 2023-08-04 |
| M71003850000 | Bayou™ troCarWash System Controller | BIOTEX, INC. | 2023-08-04 |
| 50603468009438 | CS-05-30-315 OpClear Disposable | CIPHER SURGICAL LIMITED | 2022-12-22 |
| 50603468009360 | CS-05-00-315 OpClear Disposable | CIPHER SURGICAL LIMITED | 2022-12-22 |
| 50603468009292 | CS-05-30-300 OpClear Disposable | CIPHER SURGICAL LIMITED | 2022-12-22 |
| 50603468009124 | CS-05-00-300 OpClear Disposable | CIPHER SURGICAL LIMITED | 2022-12-22 |
| 50603468009056 | CS-05-30-290 OpClear Disposable | CIPHER SURGICAL LIMITED | 2022-12-22 |
| 50603468008998 | CS-05-00-290 OpClear Disposable | CIPHER SURGICAL LIMITED | 2022-12-22 |
| 40677964031609 | ENDOGATOR | MEDIVATORS INC. | 2022-07-29 |
| 50603468008370 | CS-10-00-300 OpClear Disposable | CIPHER SURGICAL LIMITED | 2021-10-01 |
| 50603468008448 | CS-10-30-300 OpClear Disposable | CIPHER SURGICAL LIMITED | 2021-10-01 |
| 50603468008516 | CS-10-00-315 OpClear Disposable | CIPHER SURGICAL LIMITED | 2021-10-01 |
| 50603468008684 | CS-10-30-315 OpClear Disposable | CIPHER SURGICAL LIMITED | 2021-10-01 |
| 50603468008752 | CS-10-00-330 OpClear Disposable | CIPHER SURGICAL LIMITED | 2021-10-01 |
| 50603468008820 | CS-10-30-330 OpClear Disposable | CIPHER SURGICAL LIMITED | 2021-10-01 |
| 50603468007212 | CS-OS10-00 OpClear Disposable | CIPHER SURGICAL LIMITED | 2019-07-08 |
| 50603468007144 | CS-SR10-30 OpClear Disposable | CIPHER SURGICAL LIMITED | 2019-07-08 |
| 50603468007076 | CS-SR10-00 OpClear Disposable | CIPHER SURGICAL LIMITED | 2019-07-08 |
| 50603468003184 | CS-CU15-03 OpClear Control Unit | CIPHER SURGICAL LIMITED | 2019-07-08 |
| 08714729991144 | OrcaPod™ | BOSTON SCIENTIFIC CORPORATION | 2019-06-14 |
| 08714729981572 | OrcaPod™ | BOSTON SCIENTIFIC CORPORATION | 2018-10-22 |
| 00677964058455 | ENDOGATOR | MEDIVATORS INC. | 2016-09-22 |
| 00677964058462 | ENDOGATOR | MEDIVATORS INC. | 2016-09-22 |
| 00677964058479 | ENDOGATOR | MEDIVATORS INC. | 2016-09-22 |
| 00677964058486 | ENDOGATOR | MEDIVATORS INC. | 2016-09-22 |
| 00677964058493 | ENDOGATOR | MEDIVATORS INC. | 2016-09-22 |