FDA 510(k)

EndoGator 内窥镜冲洗管

K号: K220395 · 2022-03-11

决定日期2022-03-11

产品代码FEQ

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决定实质等同

器械摘要

EndoGator Endoscopy Irrigation Tubing is the device name listed in this FDA 510(k) record. The listed applicant is STERIS Corporation. It received FDA 510(k) clearance on 2022-03-11 under 510(k) number K220395. The device is classified under product code FEQ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the EndoGator Endoscopy Irrigation Tubing?

EndoGator Endoscopy Irrigation Tubing is a medical device that received FDA 510(k) clearance on 2022-03-11. The listed applicant is STERIS Corporation. The 510(k) number is K220395.

When did EndoGator Endoscopy Irrigation Tubing receive FDA 510(k) clearance?

EndoGator Endoscopy Irrigation Tubing received FDA 510(k) clearance on 2022-03-11, under 510(k) number K220395.

Who is the listed applicant for EndoGator Endoscopy Irrigation Tubing?

The FDA 510(k) record lists STERIS Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EndoGator Endoscopy Irrigation Tubing?

The FDA product code for EndoGator Endoscopy Irrigation Tubing is FEQ.

列明STERIS Corporation为申报人的其他记录

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

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相关器械（代码：FEQ）

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K191559AquaShield 系统 CO2, AquaShield 系统 CO2-PENTAX, AquaShield 系统 CO2-FUJIFILMUnited States Endoscopy Group, Inc.K182258AquaShield 系统 CO2 ; AquaShield 系统 CO2 - PENTAX ; AquaShield 系统 CO2 - FujifilmUnited States Endoscopy Group, Inc.K173650AquaShield 系统 CO2- FujifilmUnited States Endoscopy Group, Inc.K163424AquaShield 系统 - PENTAX, AquaShield 系统 CO2 - PENTAX, AquaShield 系统 CO2 - FUJINONUnited State Endoscopy Group, Inc.K162152Erbe 的 CO2 管/盖套装Erbe USA, Inc.K161482EndoChoice 水瓶盖冲洗系统Endochoice, Inc.

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