Erbe's Tubing/Cap Sets
K-Number: K221177 · 2022-08-11
ApplicantErbe USA, Inc.
Decision Date2022-08-11
Product CodeOCX
Advisory CommitteeGU
DecisionSubstantially Equivalent
Device Summary
Erbe's Tubing/Cap Sets is a medical device manufactured by Erbe USA, Inc.. It received FDA 510(k) clearance on 2022-08-11 under approval number K221177. The device is classified under product code OCX. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Erbe's Tubing/Cap Sets?
Erbe's Tubing/Cap Sets is a medical device that received FDA 510(k) clearance on 2022-08-11. It is manufactured by Erbe USA, Inc.. The 510(k) number is K221177.
When was Erbe's Tubing/Cap Sets approved by the FDA?
Erbe's Tubing/Cap Sets received FDA 510(k) clearance on 2022-08-11, under approval number K221177.
What company makes Erbe's Tubing/Cap Sets?
Erbe's Tubing/Cap Sets is manufactured by Erbe USA, Inc..
What is the FDA product code for Erbe's Tubing/Cap Sets?
The FDA product code for Erbe's Tubing/Cap Sets is OCX.
Other Devices by Erbe USA, Inc.
Related Devices (Code: OCX)
K161167Seal Single-Use Biopsy ValveEndochoice, Inc.
K152278ENDOFLOW II - Irrigation, Warming and Suction SystemPromepla Sam
K182444ERBEFLO Olympus Scope Port ConnectorErbe USA, Inc.
K182275Seal Single Use Biopsy ValveBoston Scientific Corporation
K181509Endorate Valve SetsSmartdata Suzhou Co., Ltd.
K173758Disposable Biopsy ValveZhejiang Chuangxiang Medical Technology Co., Ltd.
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.