# K251743: SPI LaproSac™ Laparoscopic Single-Use Rip-Stop Nylon Specimen Retrieval System

- Pathway: 510(k) (Traditional)
- Applicant: Surgical Principals, Inc.
- Decided: Sep 22, 2025 after 108 days
- Product code: GCJ (Laparoscope, General & Plastic Surgery)
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K982073 (1998). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K111845: The Espiner Sac or E Sac, Espiner Medical Limited (2011) Summary page 5.

## Indications for use
The LaproSac TM Specimen Retrieval Bags is indicated for use in surgical procedures to capture organs or tissue to be removed from the body cavity during Laparoscopic Surgery.

Source page: https://510kreport.com/device/K251743
Methodology: https://510kreport.com/methodology