FDA 510(k)

SPI LaproSac® 腹腔镜单次使用撕裂止尼龙标本采集系统

K号: K251743 · 2025-09-22

决定日期2025-09-22

产品代码GCJ

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决定实质等同

器械摘要

SPI LaproSac™ Laparoscopic Single-Use Rip-Stop Nylon Specimen Retrieval System is the device name listed in this FDA 510(k) record. The listed applicant is Surgical Principals, Inc.. It received FDA 510(k) clearance on 2025-09-22 under 510(k) number K251743. The device is classified under product code GCJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the SPI LaproSac™ Laparoscopic Single-Use Rip-Stop Nylon Specimen Retrieval System?

SPI LaproSac™ Laparoscopic Single-Use Rip-Stop Nylon Specimen Retrieval System is a medical device that received FDA 510(k) clearance on 2025-09-22. The listed applicant is Surgical Principals, Inc.. The 510(k) number is K251743.

When did SPI LaproSac™ Laparoscopic Single-Use Rip-Stop Nylon Specimen Retrieval System receive FDA 510(k) clearance?

SPI LaproSac™ Laparoscopic Single-Use Rip-Stop Nylon Specimen Retrieval System received FDA 510(k) clearance on 2025-09-22, under 510(k) number K251743.

Who is the listed applicant for SPI LaproSac™ Laparoscopic Single-Use Rip-Stop Nylon Specimen Retrieval System?

The FDA 510(k) record lists Surgical Principals, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SPI LaproSac™ Laparoscopic Single-Use Rip-Stop Nylon Specimen Retrieval System?

The FDA product code for SPI LaproSac™ Laparoscopic Single-Use Rip-Stop Nylon Specimen Retrieval System is GCJ.

列明Surgical Principals, Inc.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：GCJ）

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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