ENDOFLATOR +
K-Number: K250388 · 2025-09-22
ApplicantKarl Storz SE & CO. KG
Decision Date2025-09-22
Product CodeHIF
Advisory CommitteeOB
DecisionSubstantially Equivalent
Device Summary
ENDOFLATOR + is a medical device manufactured by Karl Storz SE & CO. KG. It received FDA 510(k) clearance on 2025-09-22 under approval number K250388. The device is classified under product code HIF. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the ENDOFLATOR +?
ENDOFLATOR + is a medical device that received FDA 510(k) clearance on 2025-09-22. It is manufactured by Karl Storz SE & CO. KG. The 510(k) number is K250388.
When was ENDOFLATOR + approved by the FDA?
ENDOFLATOR + received FDA 510(k) clearance on 2025-09-22, under approval number K250388.
What company makes ENDOFLATOR +?
ENDOFLATOR + is manufactured by Karl Storz SE & CO. KG.
What is the FDA product code for ENDOFLATOR +?
The FDA product code for ENDOFLATOR + is HIF.
Other Devices by Karl Storz SE & CO. KG
Related Devices (Code: HIF)
K162648U-Blade Veress NeedleTianjin Uwell Medical Device Manufacturing Co., Ltd.
K153367S698 Symbioz flowSopro - Acteon Group
K153513Insufflator 50L FM134W.O.M. World of Medicine GmbH
K170799AP 50/30 Insufflator with Insuflow PortLexion Medical, LLC
K162582HumiGard Surgical Humidification System, HumiGard Humdified Insufflation KitFisher & Paykel Healthcare
K171139LaparoLight Veress NeedleBuffalo Filter, LLC
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.