FDA 510(k)

电外科手术发生器 ESG-400，脚踏开关，POWERSEAL 弯形夹持器和分隔器，双动作

K号: K203682 · 2021-05-17

决定日期2021-05-17

产品代码GEI

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决定实质等同

器械摘要

Electrosurgical Generator ESG-400, Foot Switches, POWERSEAL Curved Jaw Sealer and Divider, Double Action is the device name listed in this FDA 510(k) record. The listed applicant is Olympus Winter & Ibe GmbH. It received FDA 510(k) clearance on 2021-05-17 under 510(k) number K203682. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Electrosurgical Generator ESG-400, Foot Switches, POWERSEAL Curved Jaw Sealer and Divider, Double Action?

Electrosurgical Generator ESG-400, Foot Switches, POWERSEAL Curved Jaw Sealer and Divider, Double Action is a medical device that received FDA 510(k) clearance on 2021-05-17. The listed applicant is Olympus Winter & Ibe GmbH. The 510(k) number is K203682.

When did Electrosurgical Generator ESG-400, Foot Switches, POWERSEAL Curved Jaw Sealer and Divider, Double Action receive FDA 510(k) clearance?

Electrosurgical Generator ESG-400, Foot Switches, POWERSEAL Curved Jaw Sealer and Divider, Double Action received FDA 510(k) clearance on 2021-05-17, under 510(k) number K203682.

Who is the listed applicant for Electrosurgical Generator ESG-400, Foot Switches, POWERSEAL Curved Jaw Sealer and Divider, Double Action?

The FDA 510(k) record lists Olympus Winter & Ibe GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Electrosurgical Generator ESG-400, Foot Switches, POWERSEAL Curved Jaw Sealer and Divider, Double Action?

The FDA product code for Electrosurgical Generator ESG-400, Foot Switches, POWERSEAL Curved Jaw Sealer and Divider, Double Action is GEI.

列明Olympus Winter & Ibe GmbH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。

K260649OES ELITE 球囊内镜及其附件；球囊，17 Fr. (WA2C17BO)；球囊，19.8 Fr. (WA2C19BO)；球囊，21 Fr. (WA2C21BO)；球囊，21 Fr.，用于带斜坡的套管 (WA2C21RO)；球囊，21 Fr.，长 (WA2C21LO)；球囊，21 Fr.，用于直型套管 (WA2C21SO)；球囊，22.5 Fr. (WA2C22BO)；球囊，25 Fr. (WA2C25BO)；光学球囊，19.8 Fr. (WA2C19BV)；光学球囊，21 Fr. (WA2C21BV)；光学球囊，21 Fr.，用于直型套管 (WA2C21SV)；光学球囊，K252043双极治疗仪CelonProBreath (WB990310)；双极治疗仪CelonProSleep plus (WB990311)；双极治疗仪CelonProBreath (WB990210)；双极治疗仪CelonProSleep plus (WB990211)K231777电外科手术发生器 ESG-410 及附件（WA91327U，WA91327W），附件：脚踏开关（WA91311W，WA91321W）K221522HF-cables（可重复使用）K223183光导电缆 K213207套管，旋塞附件

查看所有 22 个设备 →

相关器械（代码：GEI）

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。

K254196HARMONIC 1100 剪刀（HAR1120）；HARMONIC 1100 剪刀（HAR1136）Ethicon Endo-Surgery, LLC K261959Neptune® SafeAir® 10英尺烟雾排放笔，方形涂层，70mm刀片，推钮开关（0703-046-100）；Neptune® SafeAir® 10英尺烟雾排放笔，方形涂层，推钮开关，大批量非无菌（0703-046-102）；Neptune® SafeAir® 10英尺烟雾排放笔，方形涂层，70mm刀片，旋转开关（0703-047-100）；Neptune® SafeAir® 10英尺烟雾排放笔，方形涂层，旋转开关，大批量非无菌（0703-047-102）Stryker Instruments K261070LigaSure™ RAS 马里兰州颚部血管封合/分割器，纳米涂层Covidien, LLC K254185Potenza PrimeJeisys Medical Incorporated K262364艾利安谜团射频设备Ellian Corp K253859Scarlet Pro（Scarlet Pro）VIOL Co., Ltd.

官方来源

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