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FDA 510(k)

SPI LaproSac™ Laparoscopic Single-Use Rip-Stop Nylon Specimen Retrieval System

K-Number: K251743 · 2025-09-22

ApplicantSurgical Principals, Inc.
Decision Date2025-09-22
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

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.

Frequently Asked Questions

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.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07512973Single-channel Fibroid Morcellation System Used in Clinical Research on Laparoscopic MyomectomyNOT_YET_RECRUITING

Other records listing Surgical Principals, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K230621LaproGlide™ Disposable Monopolar PTFE Coated Laparoscopic Probes

Related Devices (Code: GCJ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261139VereSee (VER150, VER200, VER151, VER201, VER200C, and VER-100-103)Freyja Healthcare, LLCK253541EZ-Close™ (EZ Close Port Site Closing Device, EZ Close MAX Port Site Closing Device, EZ Close II Port Site Closing Device)Medical ImpactK261614LED LCD Monitor (OEV-271H)Lg Electronics.IncK261249Universal Seal (5-12 mm)Intuitive Surgical, Inc.K260710FloShield Air System (FSS-01-1000T - 10mm, 0 Degree FloShield Air, FSS-02-1030T - 10mm, 30 Degree FloShield Air, FSS-03-1045T - 10mm, 45 Degree FloShield Air, FSS-01-0500T - 5mm, 0 Degree FloShield Air, FSS-02-0530T - 5mm, 30 Degree FloShield Air, FSS-01-0545T - 5mm, 45 Degree FloShield Air)FloShield, Inc.K260414“Tech-Image” Video Endoscope SystemTech-Image CO., LTD.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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