# K910914: Surgical Tissue Pouch

- Pathway: 510(k) (Traditional)
- Applicant: Cook Urological, Inc.
- Decided: Mar 28, 1991 after 23 days
- Product code: KGY (Bag, Intestine)
- Device class: 1
- Regulation: 21 CFR 878.4100
- 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.
8 later devices descend from it; 2 cite it directly.
0 of 9 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
- K142427: Tissue Containment System; 10, 14, 17, 25 (2014), 5 descendants of its own
- K211043: Alexis Contained Extraction System (2022), 1 descendant of its own
- K211234: RedEx (2021), 1 descendant of its own
- K150781: Tissue Removal Pouch (2015), 1 descendant of its own
- K013872: Rusch Memory Bag (2002), 1 descendant of its own

## Recalls of this device
- May 14, 2015 · Class II · Z-1830-2015: Includes Information not stated in the intended use.

Source page: https://510kreport.com/device/K910914
Methodology: https://510kreport.com/methodology