Polygon 切除器
K号: K182675 · 2019-01-04
广告
决定日期2019-01-04
产品代码HIH
咨询委员会OB
请注意，由于您没有提供具体的医疗设备监管文本，我无法进行翻译。请提供具体的文本内容，以便我能够按照您的要求进行翻译。
决定实质等同
器械摘要
Polygon Resection Device is the device name listed in this FDA 510(k) record. The listed applicant is Polygon Medical, Inc.. It received FDA 510(k) clearance on 2019-01-04 under 510(k) number K182675. The device is classified under product code HIH. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Polygon Resection Device?
Polygon Resection Device is a medical device that received FDA 510(k) clearance on 2019-01-04. The listed applicant is Polygon Medical, Inc.. The 510(k) number is K182675.
When did Polygon Resection Device receive FDA 510(k) clearance?
Polygon Resection Device received FDA 510(k) clearance on 2019-01-04, under 510(k) number K182675.
Who is the listed applicant for Polygon Resection Device?
The FDA 510(k) record lists Polygon Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Polygon Resection Device?
The FDA product code for Polygon Resection Device is HIH.
相关临床试验
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。
相关器械（代码：HIH）
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。
K254252UNIDRIVE SIII 系统；霍普金斯望远镜 0º（26205AMA）操作套管（26205CD）闭孔器（26205OC）剃刀刀片（26205SA）剃刀刀片（26205SB）剃刀刀片（091133-01/-10）剃刀刀片（091134-01/-10）Karl Storz SE & CO. KGK261102UNIDRIVE选择系统Karl Storz SE & CO. KGK254294一次性使用数字宫腔镜（GYUT-A 12.6- 0，GYUT-A12.6- 12，GYUT-A 12.6- 22，GYUT-A 12.6- 30，GYUT-A 14.4- 0，GYUT-A 14.4- 12，GYUT-A 14.4- 22，GYUT-A 14.4- 30，GYUT-B 15- 0，GYUT-B 15- 12，GYUT-B 15-22，GYUT-B 15- 30）Zhejiang Geyi Medical Instrument Co., Ltd.K260984HERizon RD5 切除装置（5FR1PK）；HERizon RD5 切除装置 - 5套装（5FR5PK）Axora Medical, Inc.K253020Strauss Surgical切除工具American Medical Endoscopy, Inc.K254050手动组织移除装置Suzhou AcuVu Medical Technology Co., Ltd.
官方来源
在 FDA 数据库中查看 →数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。
广告