Insufflator, Automatic Carbon-dioxide For Endoscope
Gastroenterology, Urology · 21 CFR 876.1500
Recent MDR events
540 adverse event reports on file
- ENDOFLATOR 40Jul 30, 2026MalfunctionKarl Storz Se & Co. Kg9610617-2026-01781
- ENDOFLATOR 50Jul 30, 2026MalfunctionKarl Storz Se & Co. Kg9610617-2026-01785
- ENDOFLATOR 40Jul 27, 2026InjuryKarl Storz Se & Co. Kg9610617-2026-01728
- ENDOFLATOR 40Jul 27, 2026InjuryKarl Storz Se & Co. Kg2020550-2026-01728
- ENDOFLATOR 50Jul 27, 2026MalfunctionKarl Storz Se & Co. Kg9610617-2026-01735
- ENDOFLATOR 50Jul 21, 2026MalfunctionKarl Storz Se & Co. Kg9610617-2026-01693
- UNIDENTIFIEDJul 16, 2026Injury1000513161-2026-00017
- ENDOFLATOR 50Jul 15, 2026MalfunctionKarl Storz Se & Co. Kg9610617-2026-01637
- ENDOFLATOR 50Jul 15, 2026MalfunctionKarl Storz Se & Co. Kg9610617-2026-01642
- ENDOFLATOR 40Jul 14, 2026MalfunctionKarl Storz Se & Co. Kg9610617-2026-01606
Event type breakdown
Recalls
2 recall events for this product code
- Pentax Medical CompanyTerminatedOct 28, 2013
PENTAX Endoscopic Accessories. OF-B194. Made in Japan.
PENTAX Medical has become aware of a product issue associated with the OF-B194 Gas/Water Feeding Valve. A manufacturing defect may cause improper stoppage of CO2 gas during an endoscopic procedure with the potential for serious hazard to and/or user.
Z-0084-2014 · View FDA record ↗ - Northgate Technologies, Inc.TerminatedUnknown
Steris CO2MPACT Endoscopic Insufflator system, Catalog Number 72-00310-0 / 710300 - Product Usage: designed to use CO2 as a distention media in the gastrointest
An internal tubing component in the flow path was made with incorrect material which was not tested for use with this device.
Z-1148-2021 · View FDA record ↗
Registered firms
52 firms currently registered for this product code
Jiana Sterilization Technology (hangzhou) Co., Ltd
Hangzhou Zhejiang, CN
E-z-em, Inc.
Princeton, NJ, US
United States Endoscopy Group, Inc.
Mentor, OH, US
Sterigenics Us Llc
Gurnee, IL, US
Changzhou Intl. Trade & Enterprises Cooperative Co., Ltd.
changzhou Jiangsu, CN
Arthrex Do Brazil Importacao E Comercio De Equipamentos Medicos Ltda
Sao Paulo, BR
Smith & Nephew Inc.
ANDOVER, MA, US
Karl Storz Endoscopy-america, Inc.
Auburn, MA, US
Pentax Of America, Inc.
MONTVALE, NJ, US
Nextphase Medical Devices, Llc
MANSFIELD, MA, US
Storz Endoskop Produktions Gmbh
SCHAFFHAUSEN, CH
Karl Storz Se & Co. Kg
TUTTLINGEN Baden-Wurttemberg, DE
Vietmedical Distribution Joint Stock Company
Hanoi Ha Noi, VN
Olympus Medical Systems Corp.
HACHIOJI-SHI Tokyo, JP
Shirakawa Olympus Co., Ltd.
NISHISHIRAKAWA-GUN Fukushima, JP
Availmed S.a.de C.v.
Tijuana Baja California, MX
Palliare
Galway, IE
Changzhou Endoclean Medical Device Co., Ltd.
Changzhou Jiangsu, CN
Karl Storz Se & Co Kg
TUTTLINGEN Baden-Wurttemberg, DE
Fujifilm Corporation Medical Systems Research & Development Center Kaisei
Ashigarakami-Gun Kanagawa, JP
Richard Wolf Gmbh
KNITTLINGEN Baden-Wurttemberg, DE
510(k) clearances
25 clearances for this product code
- VISION MEDICAL Co., Ltd.Jul 24, 2026
K262152 · VS-370CF, VS-370CT
- Ide Vision, Ltd.Oct 30, 2024
K240847 · MedicCO2LON (MedicCO2LON)
- Palliare , Ltd.Mar 24, 2023
K230474 · EVA5 Insufflator
- Palliare , Ltd.Jul 8, 2021
K202922 · END 200 Endoscopic Tubeset
- Karl Storz Endoscopy America, Inc.Jun 23, 2020
K201096 · CO2mbiLED
- Baronova, Inc.May 14, 2019
K190985 · BAROnova Insufflation System, BAROnova Accessory Kit
- Fujifilm CorporationMay 25, 2018
K180711 · FUJIFILM Endoscopic CO2 Regulator GW-100
- Nexcore Technology, LLCSep 29, 2016
K162332 · Nexcore GI Insufflator