510(k) · Cleared
ClearedSumo Access and Tissue Resection System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Apollo Endosurgery, Inc. · ODC Endoscope Channel Accessory
Cleared on Oct 28, 2011 as substantially equivalent to K061222 (Medi-Globe Corp., 2006) and 4 other predicates after a 367-day review. Its family tree reaches back 4 generations to 1986.
- Decided
- Oct 28, 2011
- Review
- 367 days
- Class
- Class II
- Product code
- ODC
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 4 generations to K853585 (1986). 16 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK853585 Olympus Evs-Endoscopic Video Image & Data SysOlympus Corp. · 1986 · Recalled
- 3 generations backK954451 Evis 140 SystemOlympus America, Inc. · 1996 · Recalled
- 2 generations backK984358 Olympus Distal Attachment, Models…Olympus America, Inc. · 1999 · Recalled
- 1 generation backK050578 Cook Ireland Duette Multi-Band Mucosectomy DeviceCook Ireland, Ltd. · 2005
- This deviceK103155 Sumo Access and Tissue Resection SystemApollo Endosurgery, Inc. · 2011
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K853585 | Olympus Evs-Endoscopic Video Image & Data Sys | Olympus Corp. | 1986 | 2 |
| −3 | K954451 | Evis 140 System | Olympus America, Inc. | 1996 | 3 |
| −2 | K984358 | Olympus Distal Attachment, Models… | Olympus America, Inc. | 1999 | 2 |
| −1 | K050578 | Cook Ireland Duette Multi-Band Mucosectomy Device | Cook Ireland, Ltd. | 2005 | — |
| 0 (this device) | K103155 | Sumo Access and Tissue Resection System | Apollo Endosurgery, Inc. | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 2 | 0 |
| 2000 | 2 | 0 |
| 2002 | 1 | 0 |
| 2004 | 1 | 0 |
| 2006 | 1 | 0 |
| 2008 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in ODC? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new ODC device
- #1 K232329 Defendo Fujifilm 700 Single Use Biopsy Valve…score 14.0 · 6 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (5)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K061222 | Injectra Injection NeedleSummary page 2…estinal tract. The SuN10T5 Snare is intended to remove polyps and small tumors from the gastrointestinal tract. Predicate Devices K061222 Injectra Injection Needle Medi-Globe Corp K0821 14 Electrocautery Dilation Balloon Apo… | 2006 |
| * | K082114 | Electrocautery Dilation Balloon, Models: Edb-0018-00, Edb-0020-00, Edb-0022-00Summary page 2…tumors from the gastrointestinal tract. Predicate Devices K061222 Injectra Injection Needle Medi-Globe Corp K0821 14 Electrocautery Dilation Balloon Apollo Endosurgery K042412 Spacemaker Balloon U… | 2008 |
| * | K042412 | Modified Spacemaker SystemSummary page 2…K061222 Injectra Injection Needle Medi-Globe Corp K0821 14 Electrocautery Dilation Balloon Apollo Endosurgery K042412 Spacemaker Balloon US Surgical K943935 Polypectomy Snare Medi-Gl… | 2004 |
| * | K943935 | Gip/Medi-Globe Polypectomy SnaresSummary page 2…Corp K0821 14 Electrocautery Dilation Balloon Apollo Endosurgery K042412 Spacemaker Balloon US Surgical K943935 Polypectomy Snare Medi-Globe Corp K050578 Duette Muscosectomy Coo… | 1995 |
| * | K050578 | Cook Ireland Duette Multi-Band Mucosectomy DeviceSummary page 2…surgery K042412 Spacemaker Balloon US Surgical K943935 Polypectomy Snare Medi-Globe Corp K050578 Duette Muscosectomy Cook Device Description The Apollo Endosurgery SuMO Access and Tissue… | 2005 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 25 years and passes through 4 companies; a new generation was cleared every 6.5 years on median.
- 3 of the 16 ancestors have a recall of any class.
- 2 other devices also cite its predicate K061222.
How does its category compare?
All ODC devicesODC Endoscope Channel Accessory: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
FDA decisions per year · ODC
6in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · ODC
106in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · ODC
1so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · ODC
91in 2025
MAUDE reports naming product code ODC, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 3 | 83 | 0 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 4 | 67 | 0 | 0 |
| 2011 | 4 | 143 | 0 | 0 |
| 2012 | 2 | — | 0 | 1 |
| 2013 | 0 | — | 0 | 1 |
| 2014 | 0 | — | 0 | 2 |
| 2015 | 2 | — | 0 | 3 |
| 2016 | 1 | — | 0 | 8 |
| 2017 | 1 | — | 0 | 12 |
| 2018 | 2 | — | 0 | 17 |
| 2019 | 4 | 55 | 0 | 40 |
| 2020 | 4 | 128 | 0 | 54 |
| 2021 | 6 | 181 | 0 | 52 |
| 2022 | 8 | 118 | 0 | 37 |
| 2023 | 7 | 126 | 0 | 43 |
| 2024 | 8 | 95 | 0 | 100 |
| 2025 | 6 | 106 | 0 | 91 |
| 2026 | 1 | — | 1 | — |
What is it indicated for?
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…
Read the full statement (102 words)
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K103155 · printed Nov 6, 2026
Cite this page
510(k) Report. “K103155: Sumo Access and Tissue Resection System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K103155
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026