510(k) · Cleared
ClearedInscope Multi-Clip Applier, Models IN22321, IN23321
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ethicon Endo-Surgery, Inc. · MND Ligator, Esophageal
Cleared on Oct 7, 2005 after an 81-day review. The FDA summary names its predicate without a number. 8 later devices descend from it.
- Decided
- Oct 7, 2005
- Review
- 81 days
- Class
- Class II
- Product code
- MND
- Recalls
- None
- Predicates
- 0
8 later devices descend from it, 2 citing it directly.
- This deviceK051950 Inscope Multi-Clip Applier, Models IN22321, IN23321Ethicon Endo-Surgery, Inc. · 2005
- Descendant · cites it directly · 6 of its ownK101428 Otsc (Over-the Scope-Clip) System SetOvesco Endoscopy AG · 2010
- Descendant · 2 generations on · 2 of its ownK120814 Padlock Clip-12Aponos Medical Corp. · 2012 · Recalled
- Descendant · 2 generations on · 1 of its ownK241858 BARS Set (100.60)Ovesco Endoscopy AG · 2024
- Descendant · 3 generations on · 1 of its ownK180689 Padlock Clip defect closure device; Padlock Clip Pro-Select defect…STERIS Corporation · 2018
- Descendant · 3 generations on · 0 of its ownK251562 OTSCneo System Set (100.03n-14n, 100.27n-31n)Ovesco Endoscopy AG · 2025
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K101428Otsc (Over-the Scope-Clip) System SetOvesco Endoscopy AG · 2010 · cites it directly6descendants
- K120814Padlock Clip-12Aponos Medical Corp. · 2012 · 2 generations on2descendants
- K241858BARS Set (100.60)Ovesco Endoscopy AG · 2024 · 2 generations on1descendant
- K180689Padlock Clip defect closure device; Padlock Clip Pro-Select defect closure deviceSTERIS Corporation · 2018 · 3 generations on1descendant
- K251562OTSCneo System Set (100.03n-14n, 100.27n-31n)Ovesco Endoscopy AG · 2025 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K051950 | Inscope Multi-Clip Applier, Models IN22321, IN23321 | Ethicon Endo-Surgery, Inc. | 2005 | — |
| +1 | K101428 | Otsc (Over-the Scope-Clip) System Set | Ovesco Endoscopy AG | 2010 | — |
| +2 | K120814 | Padlock Clip-12 | Aponos Medical Corp. | 2012 | 1 |
| +2 | K241858 | BARS Set (100.60) | Ovesco Endoscopy AG | 2024 | — |
| +3 | K180689 | Padlock Clip defect closure device; Padlock Clip Pro-Select defect closure… | STERIS Corporation | 2018 | — |
| +3 | K251562 | OTSCneo System Set (100.03n-14n, 100.27n-31n) | Ovesco Endoscopy AG | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 2 | 0 |
| 2012 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2022 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 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 MND? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | — | Syntheon, LLC: Endoscopic Multi-Fire Clip Applier Named without a submission number | |
| * | — | Olympus Optical Co., Ltd.: Rotatable Clip Fixing Device HX-5/6-1 Named without a submission number |
What descends from it? (8)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- Of its descendants, K101428 (Ovesco Endoscopy AG, 2010) has gone furthest, with 6 descendants of its own.
How does its category compare?
All MND devicesMND Ligator, Esophageal: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MND
1in 2013
2026 to Oct 25, outlined.
Median 510(k) review, days · MND
Too few MND 510(k)s in any year since 2007 to give a median.
Recalls per year · MND
1in 2025
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · MND
1,083in 2025
MAUDE reports naming product code MND, 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 | 84 |
| 2008 | 1 | — | 0 | 451 |
| 2009 | 1 | — | 0 | 1,161 |
| 2010 | 0 | — | 1 | 600 |
| 2011 | 0 | — | 1 | 672 |
| 2012 | 0 | — | 0 | 719 |
| 2013 | 1 | — | 0 | 750 |
| 2014 | 0 | — | 0 | 117 |
| 2015 | 0 | — | 0 | 76 |
| 2016 | 0 | — | 0 | 94 |
| 2017 | 0 | — | 0 | 88 |
| 2018 | 0 | — | 0 | 124 |
| 2019 | 0 | — | 0 | 294 |
| 2020 | 0 | — | 1 | 345 |
| 2021 | 0 | — | 0 | 674 |
| 2022 | 0 | — | 0 | 808 |
| 2023 | 0 | — | 0 | 689 |
| 2024 | 0 | — | 0 | 921 |
| 2025 | 0 | — | 1 (1) | 1,083 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The InScope Multi-Clip Applier is indicated for use with an endoscope to place clips in the gastrointestinal (GI) tract for the purpose of:
Endoscopic marking,
Hemostasis for:
Mucosal and submucosal defects < 3 cm
Bleeding ulcers
Arteries < 2 mm
Polyps < 1.5 cm in diameter
Diverticula in the colon
Anchoring to affix jejunal feeding tubes to the wall of the small bowel,
Closure of GI tract luminal perforations < 20 mm in patients where an alternative to surgery is required.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K051950 · printed Nov 6, 2026
Cite this page
510(k) Report. “K051950: Inscope Multi-Clip Applier, Models IN22321, IN23321.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K051950
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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