# K923945: Pleatman Sac Specimen Container

- Pathway: 510(k) (Traditional)
- Applicant: Cabot Medical Corp.
- Decided: Feb 5, 1993 after 185 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.
5 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)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K012150: Patton Endo-Bag (2001), 4 descendants of its own
- K030422: Lina-Bag, Models LB-60, LB-100 (2003), 3 descendants of its own
- 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

## Recalls of this device
- Aug 3, 2010 · Not classified · Z-2436-2010: Gyrus Medical, Inc. has issued a Urgent Medical Device Recall for the Gyrus ACMI product 004942-903 - Pleatman Sac Tissue Removal System, sold as lot 186540FC with an expiration date of 06/2015. As a 

Source page: https://510kreport.com/device/K923945
Methodology: https://510kreport.com/methodology