# K030422: Lina-Bag, Models LB-60, LB-100

- Pathway: 510(k) (Traditional)
- Applicant: Lina Medical Cml Aps
- Decided: Apr 14, 2003 after 63 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 K923945 (1993). 4 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K012150: Patton Endo-Bag, Patton Medical Corp. (2001)
- K933104: One-Handed Endopouch Specimen Retrieval Bag, ETHICON, Inc. (1993) Summary page 1.
- K922123: Auto Suture Disposable Endoscopic Specimen Pouch, United States Surgical, A Division of Tyco Healthc (1993) Summary page 1.

## Most influential descendants
- K033842: Nubert, Albert and Hubert Impervious Bags for Endoscopic Retrieval of Tissue (2004), 2 descendants of its own
- K123728: Retrieval Bag (2013), 1 descendant of its own
- K210248: Lab Bag with Fabric Pouch (2021), 0 descendants of its own

## Indications for use
A single use retrieval bag designed to temporarily contain organs or stones and facilitate their removal from the patient witbout contamination during laparoscopic surgery such as the appendix, an ectopic pregnancy, gallbladder. gallstones, lymph nodes, ovaries, fibroid tumors, small sections of bowel and other tissue structures.

Source page: https://510kreport.com/device/K030422
Methodology: https://510kreport.com/methodology