Product code FEQ— Gastroenterology, Urology
ENDOCHOICE WATER BOTTLE CAP SYSTEM
- Classification name
- Pump, Air, Non-Manual, For Endoscope
- Device class
- Class 2
- Regulation
- 21 CFR 876.1500
- Advisory panel
- Gastroenterology, Urology
- Total cleared
- 21
- First cleared
- Most recent
Market context for product code FEQ
FDA has cleared devices under product code FEQ between 2000 and 2022, filed by 8 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
- 2022
- 2019
- 2018
- 2017
- 2016
- 2015
- 2014
- 2013
- 2012
- 2011
- 2010
- 2009
- 2000
Top applicants under product code FEQ
Adverse events under product code FEQ
product code FEQ- Malfunction
- 1,135
- Total
- 1,135
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recent clearances under product code FEQ
- K220395 — EndoGator Endoscopy Irrigation Tubing
- K191559 — AquaShield System CO2, AquaShield System CO2-PENTAX, AquaShield System CO2-FUJIFILM
- K182258 — AquaShield System CO2; AquaShield System CO2 - PENTAX; AquaShield System CO2 - Fujifilm
- K173650 — AquaShield System CO2- Fujifilm
- K163424 — AquaShield System - PENTAX, AquaShield System CO2 - PENTAX, AquaShield System CO2 - FUJINON
- K162152 — Erbes CO2 Tubing/Cap Sets
- K161482 — EndoChoice Water Bottle Cap Irrigation System
- K153588 — EndoChoice Water Bottle Cap System
- K153362 — AquaShield system CO2, AquaShield system-PENTAX
- K142155 — ENDOCHOICE WATER BOTTLE CAP SYSTEM
- K133747 — ENDOCHOICE WATER BOTTLE CAP IRRIGATION SYSTEM
- K132340 — ERBEFLO CLEVERCAP HYBRID TUBING/CAP SET FOR PENTAX SCOPES, ERBEFLO CLEVERCAP HYBRID CO2 TUBING/CAP SET FOR OLYMPUS 160/1
- K120862 — WATER BOTTLE CAP IRRIGATON SYSTEM
- K120123 — AQUASHIELD CO2 SYSTEM
- K112576 — ENDOCHOICE WATER BOTTLE CAP SYSTEM
- K103696 — ERBEFLO CLEVERCAP HYBRID TUBING/CAP SETS FOR OLYMPUS MODELS 160 AND 180 SERIES SCOPES
- K100899 — OLYMPUS ENDOSCOPIC FLUSHING PUMP, MODEL OPF-2
- K101146 — WATER BOTTLE CAP SYSTEM
- K100803 — OLYMPUS FLUSHING PUMP OFP MODEL: OFP-1
- K092429 — ENDOGATOR
- K000948 — OLYMPUS ENDOSCOPIC FLUSHING PUMP MODEL OFP-1
Data sourced from openFDA. This site is unofficial and independent of the FDA.