# K111845: The Espiner Sac or E Sac

- Pathway: 510(k) (Traditional)
- Applicant: Espiner Medical Limited
- Decided: Sep 26, 2011 after 89 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: 1 generation back to K982073 (1998). 1 ancestor in all.
5 later devices descend from it; 5 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K982073: Anchor Laparoscopic Tissue Retrieval System, Anchor Products Co. (1998) Summary page 3.

## Most influential descendants
- K251743: SPI LaproSac™ Laparoscopic Single-Use Rip-Stop Nylon Specimen Retrieval System (2025), 0 descendants of its own
- K200053: DANNIK Specimen Retrieval System with deployment mechanism, DANNIK Specimen Retrieval System (Bag Only) (2020), 0 descendants of its own
- K181791: Simplystrong, Simplyezee (2018), 0 descendants of its own
- K180114: AEON Retrieval Bag (2018), 0 descendants of its own
- K151489: Retrieval bag system (2015), 0 descendants of its own

## Recalls of this device
- Jun 20, 2018 · Class II · Z-0444-2019: Label was incorrect. The label states that the volume of the retrieval bag was 1200ml, but it should state 1000ml

## Indications for use
The Espiner Tissue Retrieval System consists of a family of impervious sacs which are sterile single use devices that can be used alone or with a dedicated introducer system for the encapture and removal of an organ, tissue or fluid from the body cavity during laparoscopic surgery.

Source page: https://510kreport.com/device/K111845
Methodology: https://510kreport.com/methodology