FDA 510(k)

ENSEAL X1 组织密封器，曲面嘴，25 cm 轴长度，ENSEAL X1 组织密封器，曲面嘴，37 cm 轴长度，ENSEAL X1 组织密封器，曲面嘴，45 cm 轴长度

K号: K201066 · 2021-01-22

决定日期2021-01-22

产品代码GEI

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决定实质等同

器械摘要

ENSEAL X1 Tissue Sealer, Curved Jaw, 25 cm Shaft Length, ENSEAL X1 Tissue Sealer, Curved Jaw, 37 cm Shaft Length, ENSEAL X1 Tissue Sealer, Curved Jaw, 45 cm Shaft Length is the device name listed in this FDA 510(k) record. The listed applicant is Ethicon Endo-Surgery, LLC. It received FDA 510(k) clearance on 2021-01-22 under 510(k) number K201066. 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 ENSEAL X1 Tissue Sealer, Curved Jaw, 25 cm Shaft Length, ENSEAL X1 Tissue Sealer, Curved Jaw, 37 cm Shaft Length, ENSEAL X1 Tissue Sealer, Curved Jaw, 45 cm Shaft Length?

ENSEAL X1 Tissue Sealer, Curved Jaw, 25 cm Shaft Length, ENSEAL X1 Tissue Sealer, Curved Jaw, 37 cm Shaft Length, ENSEAL X1 Tissue Sealer, Curved Jaw, 45 cm Shaft Length is a medical device that received FDA 510(k) clearance on 2021-01-22. The listed applicant is Ethicon Endo-Surgery, LLC. The 510(k) number is K201066.

When did ENSEAL X1 Tissue Sealer, Curved Jaw, 25 cm Shaft Length, ENSEAL X1 Tissue Sealer, Curved Jaw, 37 cm Shaft Length, ENSEAL X1 Tissue Sealer, Curved Jaw, 45 cm Shaft Length receive FDA 510(k) clearance?

ENSEAL X1 Tissue Sealer, Curved Jaw, 25 cm Shaft Length, ENSEAL X1 Tissue Sealer, Curved Jaw, 37 cm Shaft Length, ENSEAL X1 Tissue Sealer, Curved Jaw, 45 cm Shaft Length received FDA 510(k) clearance on 2021-01-22, under 510(k) number K201066.

Who is the listed applicant for ENSEAL X1 Tissue Sealer, Curved Jaw, 25 cm Shaft Length, ENSEAL X1 Tissue Sealer, Curved Jaw, 37 cm Shaft Length, ENSEAL X1 Tissue Sealer, Curved Jaw, 45 cm Shaft Length?

FDA 510(k)记录中列出Ethicon Endo-Surgery, LLC为申请人。这本身并不足以确立该设备制造商的身份。

What is the FDA product code for ENSEAL X1 Tissue Sealer, Curved Jaw, 25 cm Shaft Length, ENSEAL X1 Tissue Sealer, Curved Jaw, 37 cm Shaft Length, ENSEAL X1 Tissue Sealer, Curved Jaw, 45 cm Shaft Length?

The FDA product code for ENSEAL X1 Tissue Sealer, Curved Jaw, 25 cm Shaft Length, ENSEAL X1 Tissue Sealer, Curved Jaw, 37 cm Shaft Length, ENSEAL X1 Tissue Sealer, Curved Jaw, 45 cm Shaft Length is GEI.

列明Ethicon Endo-Surgery, LLC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。

K254196HARMONIC 1100 剪刀（HAR1120）；HARMONIC 1100 剪刀（HAR1136）K260196ETHICON™ 圆形夹持器（CDH21mm）；ETHICON™ 圆形夹持器（CDH25mm）；ETHICON™ 圆形夹持器（CDH29mm）；ETHICON™ 圆形夹持器（CDH33mm）；ETHICON™ 圆形夹持器 - XL 密封（ECS21mm）；ETHICON™ 圆形夹持器 - XL 密封（ECS25mm）；ETHICON™ 圆形夹持器 - XL 密封（ECS29mm）；ETHICON™ 圆形夹持器 - XL 密封（ECS33mm）K252906ECHELON ENDOPATH 订书线加固（ECH60R）K252739ETHICON™ 4000 45mm 紧凑夹持器（EC3DT45C）；ETHICON™ 4000 45mm 标准夹持器（EC3DT45S）；ETHICON™ 4000 45mm 长夹持器（EC3DT45L）；ETHICON™ 3D 45mm 白色重载（ER45W）；ETHICON™ 3D 45mm 蓝色重载（ER45B）；ETHICON™ 3D 45mm 绿色重载（ER45G）；ETHICON™ 3D 45mm 黑色重载（ER45T）K250835ETHICON 4000 60mm 紧凑夹持器（EC3D60C）；ETHICON 4000 60mm 标准夹持器（EC3D60S）；ETHICON 4000 60mm 长夹持器（EC3D60L）；ETHICON 3D 60mm 白色重载（ER60W）；ETHICON 3D 60mm 蓝色重载（ER60B）；ETHICON 3D 60mm 绿色重载（ER60G）；ETHICON 3D 60mm 黑色重载（ER60T）K243276ECHELON LINEAR® 钳子 30mm 钳子 (GTX30)；ECHELON LINEAR® 钳子 60mm 钳子 (GTX60)；ECHELON LINEAR® 钳子 90mm 钳子 (GTX90)；ECHELON LINEAR® 钳子 3D 30mm 蓝色重装 (GTXR30B)；ECHELON LINEAR® 钳子 3D 30mm 绿色重装 (GTXR30G)；ECHELON LINEAR® 钳子 3D 60mm 蓝色重装 (GTXR60B)；ECHELON LINEAR® 钳子 3D 60mm 绿色重装 (GTXR60G)；ECHELON LINEAR® 钳子 3D 90mm 蓝色重装 (GTXR90B)；ECHELON LINEAR® 钳子 3D 90mm 绿色重装 (GTXR90G)

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