WHERE ARE YOU?

Concept Pre-Sub Submission prep Newly cleared Raising Postmarket & security

THE TAPE

Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register

The Tracker / September 2025 / K251743

510(k) cleared

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

Surgical Principals, Inc. · Sep 22, 2025 · K251743

FDA cleared the SPI LaproSac Laparoscopic Single-Use Rip-Stop Nylon Specimen Retrieval System from Surgical Principals, Inc. on Sep 22, 2025 under K251743, a traditional 510(k). The device falls under product code GCJ, Laparoscope, General & Plastic Surgery, regulated at 21 CFR 876.1500 as a Class 2 device. The review panel was Gastroenterology, Urology.

FDA logged the submission as received on Jun 6, 2025. The decision came 108 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

This is the only decision on file for Surgical Principals, Inc. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K251743?

K251743 is the FDA 510(k) for SPI LaproSac Laparoscopic Single-Use Rip-Stop Nylon Specimen Retrieval System, submitted by Surgical Principals, Inc.. FDA's decision date was Sep 22, 2025, under product code GCJ (Laparoscope, General & Plastic Surgery).

Who makes the SPI LaproSac Laparoscopic Single-Use Rip-Stop Nylon Specimen Retrieval System?

Surgical Principals, Inc., based in Pierce, WA, is the applicant of record for K251743.

How long did the K251743 review take?

FDA received the submission on Jun 6, 2025 and issued its decision on Sep 22, 2025, 108 days later.

← All decisions in September 2025