# K180836: Genistrong

- Pathway: 510(k) (Special)
- Applicant: Genicon, Inc.
- Decided: Apr 18, 2018 after 19 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 K061555 (2006). 3 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K132375: Genistrong Single-Use Specimen Retrieval Bag, Genicon (2014) Summary page 4.

## Most influential descendants
- K232519: ENDOCOLLECT Specimen Retrieval Bag (2024), 1 descendant of its own
- K240635: ENDOCOLLECT Specimen Retrieval Bag, 8mm, ENDOCOLLECT Specimen Retrieval Bag, 12mm, ENDOCOLLECT Specimen Retrieval Bag, 15mm (2024), 0 descendants of its own

## Indications for use
The GENICON Specimen Retrieval is indicated for use in laparoscopic procedures to capture organs or tissue to be removed from the body cavity.

Source page: https://510kreport.com/device/K180836
Methodology: https://510kreport.com/methodology