# K103155: Sumo Access and Tissue Resection System

- Pathway: 510(k) (Traditional)
- Applicant: Apollo Endosurgery, Inc.
- Decided: Oct 28, 2011 after 367 days
- Product code: ODC (Endoscope Channel Accessory)
- 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: 4 generations back to K853585 (1986). 16 ancestors in all.
No later device cites it as a predicate yet.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K061222: Injectra Injection Needle, Medi-Globe Corp. (2006) Summary page 2.
- K082114: Electrocautery Dilation Balloon, Models: Edb-0018-00, Edb-0020-00, Edb-0022-00, Apollo Endosurgery, Inc. (2008) Summary page 2.
- K042412: Modified Spacemaker System, United States Surgical, A Division of Tyco Healthc (2004) Summary page 2.
- K943935: Gip/Medi-Globe Polypectomy Snares, Medi-Globe Corp. (1995) Summary page 2.
- K050578: Cook Ireland Duette Multi-Band Mucosectomy Device, Cook Ireland, Ltd. (2005) Summary page 2.

## Indications for use
The SuMOTM Access and Tissue Resection System is intended to access, dissect, and resect soft tissue in endoscopic gastrointestinal procedures such as removal of flat polyps. The Injection Needle is intended for endoscopic injection of solutions such as saline as a procedural aid in endoscopic procedures. The Tunneling Balloon is intended for soft tissue separation and dilation during endoscopic procedures. The Dilation Balloon is intended for soft tissue separation and dilation during endloscopic procedures. The Tissue Resection Tool is intended for endoscopic resection in the gastrointestinal tract. The SuMOTM Snare is intended to remove polyps and small tumors from the gastrointestinal tract.

Source page: https://510kreport.com/device/K103155
Methodology: https://510kreport.com/methodology