# K150781: Tissue Removal Pouch

- Pathway: 510(k) (Traditional)
- Applicant: Boehringer Laboratories, LLC
- Decided: Jun 19, 2015 after 86 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: 2 generations back to K910914 (1991). 3 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K142427: Tissue Containment System; 10, 14, 17, 25, Applied Medical Resources (2014) Summary page 4.
- K060051: Specimen Retrieval System, Applied Medical Resources Corp. (2006) Summary page 4.

## Most influential descendants
- K151990: Tissue Removal System (2015), 0 descendants of its own

## Indications for use
The Tissue Removal Pouch is indicated for the removal of tissue during surgical procedures and for the containment of tissue during extracorporeal manual morcellation. Contraindications: The Tissue Removal Pouch is contraindicated for laparoscopic power morcellation during gynecologic procedures. The Tissue Removal Pouch is contraindicated for use with powered cutting devices (e.g., power morcellators, electrosurgical and laser instruments), and when, in the judgment of the physician, use of such a device would be contrary to the best interest of the patient.

Source page: https://510kreport.com/device/K150781
Methodology: https://510kreport.com/methodology