# K092821: Tissuebag, Models: A10 211, A10 212, Tbi 100, TBI1011, TBI1021

- Pathway: 510(k) (Traditional)
- Applicant: Agency For Medical Innovations, Inc.
- Decided: Feb 1, 2010 after 140 days
- Product code: GCJ (Laparoscope, General & Plastic Surgery)
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K922123 (1993). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K922123: Auto Suture Disposable Endoscopic Specimen Pouch, United States Surgical, A Division of Tyco Healthc (1993) Summary page 1.

## Indications for use
The "TissueBags' are intended for safe collection and removal of specimen, such as appendix, gallbladder, myoma, cysts, ovaries, fibroid tumours and other tissues, and calculi during surgical procedures.

Source page: https://510kreport.com/device/K092821
Methodology: https://510kreport.com/methodology