# K101428: Otsc (Over-the Scope-Clip) System Set

- Pathway: 510(k) (Traditional)
- Applicant: Ovesco Endoscopy AG
- Decided: Dec 1, 2010 after 194 days
- Product code: PKL (Hemostatic Metal Clip For The Gi Tract)
- Device class: 2
- Regulation: 21 CFR 876.4400
- 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 K963160 (1997). 6 ancestors in all.
6 later devices descend from it; 3 cite it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K020824: Speedband Superview Super 7, Injection Speedband Superview Super 7, Models 4205 and 4238, Boston Scientific Corp (2002) Summary page 1.
- K040148: Resolution Hemostasis Clipping Device, Boston Scientific Corp (2004) Summary page 1.
- K051950: Inscope Multi-Clip Applier, Models IN22321, IN23321, Ethicon Endo-Surgery, Inc. (2005) Summary page 1.

## Cited in the summary but kept off the family tree
- K986669: Speedband Multiple Ligator. Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Most influential descendants
- K120814: Padlock Clip-12 (2012), 2 descendants of its own
- K241858: BARS Set (100.60) (2024), 1 descendant of its own
- K180689: Padlock Clip defect closure device; Padlock Clip Pro-Select defect closure device (2018), 1 descendant of its own
- K251562: OTSCneo System Set (100.03n-14n, 100.27n-31n) (2025), 0 descendants of its own
- K220157: Disposable Hemostatic Closure Clip Device (2022), 0 descendants of its own

## Indications for use
The OTSC system set is indicated for use in flexible endoscopy and for the compression of tissue in the gastrointestinal tract, for haemostasis or for treating lesions of the wall of gastrointestinal organs. Marking of lesions. The OTSC clip is indicated for clip placement within the gastrointestinal (GI) tract for the purpose of: - Endoscopic marking - Hemostasis for: - Mucosal/submucosal defects < 3 cm - Bleeding ulcers - Arteries < 2 mm - Polyps < 1.5 cm in diameter - Diverticula in the colon - Closure of GI tract luminal perforations < 20 mm that can be treated conservatively

Source page: https://510kreport.com/device/K101428
Methodology: https://510kreport.com/methodology