# K060051: Specimen Retrieval System

- Pathway: 510(k) (Traditional)
- Applicant: Applied Medical Resources Corp.
- Decided: Jan 19, 2006 after 13 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
No predicates in its family tree.
15 later devices descend from it; 4 cite it directly.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K100959: Specimen Retrieval System (2010), 7 descendants of its own
- K142427: Tissue Containment System; 10, 14, 17, 25 (2014), 5 descendants of its own
- K103510: Unimax Specimen Retrieval System (2011), 3 descendants of its own
- K172789: Specimen Retrieval Bag (2018), 2 descendants of its own
- K211043: Alexis Contained Extraction System (2022), 1 descendant of its own

## Recalls of this device
- Oct 21, 2013 · Class II · Z-0183-2014: Applied Medical is conducting a voluntary recall of the Inzii 12/15mm retrieval system. During shipment, the retrieval system packaging has the potential to become punctured with small holes, which co

## Indications for use
The Applied Medical 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/K060051
Methodology: https://510kreport.com/methodology