# K103510: Unimax Specimen Retrieval System

- Pathway: 510(k) (Traditional)
- Applicant: Unimax Medical Systems, Inc.
- Decided: May 6, 2011 after 158 days
- Product code: GCJ (Laparoscope, General & Plastic Surgery)
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K060051 (2006). 2 ancestors in all.
3 later devices descend from it; 2 cite 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)
- K100959: Specimen Retrieval System, Applied Medical Resources (2010) Summary page 1.

## Most influential descendants
- K141593: Unimicro Disposable Retrieval Endo-Pouch (2014), 1 descendant of its own
- K250411: DANNIK® Laparoscopic Single-Use Poly Specimen Retrieval System (2025), 0 descendants of its own
- K172578: Equipment Pouch (2017), 0 descendants of its own

## Recalls of this device
- Jun 25, 2024 · Class II · Z-3164-2024: The tube may fall into the surgical site during the grasping process.

## Indications for use
The Unimax Specimen Retrieval System is indicated for use as a receptacle for the collection and extraction of tissue, organs and calculi during general and laparoscopic surgical procedures.

Source page: https://510kreport.com/device/K103510
Methodology: https://510kreport.com/methodology