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This page describes products and general use; it is not medical advice.
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The over-the-scope clip (OTSC clip) is a nitinol clip that is mounted on a cap fitted to the tip of an endoscope. This page is for clinic staff, buyers and students who need to know what the device is, how its variants differ, how the sizes match endoscope diameters, and how the U.S. FDA classifies it.
What is an over-the-scope clip (OTSC clip)?
An over-the-scope clip is a gastrointestinal clip carried on the outside of the endoscope tip, rather than passed through the scope’s working channel. Ovesco Endoscopy describes its OTSC System Set as a flexible endoscopy instrument whose listed applications are gastrointestinal hemostasis, closure of GI wall lesions, tissue compression and lesion marking. The set contains an applicator cap with a mounted clip, a thread with thread retriever, and a hand wheel that releases the clip.
Who uses it: gastroenterology and endoscopy teams; supply and procurement staff match the clip to the endoscopes in use.
How the OTSC clip is built
Ovesco describes the OTSC as a superelastic nitinol device for compression and approximation of tissue in the digestive tract. It is delivered on an applicator cap that fits the tip of the endoscope. The manufacturer describes the clip as biocompatible and MR conditional, and as able to remain in the body as a long-term implant. Cap depth (3 mm or 6 mm) is offered by the manufacturer for capturing smaller or larger quantities of tissue; the mini size is listed only with the 6 mm depth.
Types and variants
The clip comes in three tooth shapes. The cap comes in four sizes (mini, 11, 12 and 14) and two cap depths, 3 mm and 6 mm.
| Type | Tooth design | Manufacturer’s description |
|---|---|---|
| OTSC a | Blunt teeth | Primarily compression effect |
| OTSC t | Small-spike teeth | Compression and anchoring effect |
| OTSC gc | Elongated spiked teeth | Elongated spiked teeth for gastric wall closure |
Source: Ovesco OTSCneo System Set and OTSC System Set pages, checked 2026-10-31.
Sizes that matter: matching the cap to the endoscope
The cap size is chosen against the diameter of the endoscope’s insertion part. The values below are the manufacturer’s figures for the OTSCneo system.
| Cap size | Endoscope insertion-part diameter | Maximum outer diameter (with cap) |
|---|---|---|
| mini | 8.5 to 10 mm | 14.6 mm |
| 11 | 8.5 to 11 mm | 16 mm |
| 12 | 10.5 to 12 mm | 17.4 mm |
| 14 | 11.5 to 14 mm | 20.1 mm |
Source: Ovesco OTSCneo System Set page, checked 2026-10-31. Ranges overlap, so a single endoscope can fit more than one cap size.
How the FDA classifies it
The FDA 510(k) database lists the OTSC (Over-the-Scope-Clip) System Set from Ovesco Endoscopy AG under submission K101428, decision date 12/01/2010, product code PKL, “Hemostatic Metal Clip for the GI Tract”. The product code falls under 21 CFR 876.4400. That regulation is titled hemorrhoidal ligator, places the devices in Class II (special controls), and exempts them from premarket notification except for a hemostatic metal clip intended for use in the gastrointestinal tract. In practice this means a GI hemostatic metal clip such as the OTSC needs a 510(k) clearance, unlike the other devices in that regulation.
A 510(k) record shows that a device was cleared. It is not the same as the cleared indications, which are stated in the manufacturer’s instructions for use.
How to choose
Only criteria stated by the manufacturer are listed here.
- Cap size: match the cap to the endoscope insertion-part diameter, using the table above.
- Tooth shape: a (blunt teeth), t (small spikes) or gc (elongated spiked teeth), as described in the table above.
- Cap depth: the manufacturer offers 3 mm and 6 mm.
Safe use and handling basics
The OTSC is a clinician-applied endoscopic device and must be used according to the manufacturer’s instructions for use.
Common mistakes
- Treating the OTSC as a through-the-scope clip. It is mounted on the outside of the endoscope tip, so the endoscope diameter and cap size must match.
- Reading the regulation title (hemorrhoidal ligator) as the device description. The GI hemostatic metal clip is a named exception inside that regulation.
- Assuming the OTSCneo dimensions above apply to every OTSC system. They are the OTSCneo figures.
FAQ
What is an OTSC clip?
An OTSC clip is the over-the-scope clip: a nitinol clip on an endoscope-tip cap, described by its manufacturer as a flexible endoscopy instrument for gastrointestinal hemostasis, closure of GI wall lesions, tissue compression and marking.
Is the over-the-scope clip FDA cleared?
Yes. The OTSC System Set was cleared through 510(k) K101428 with a decision date of 12/01/2010, under product code PKL and 21 CFR 876.4400.
What cap sizes does the OTSC clip come in?
Four: mini, 11, 12 and 14, each chosen against the endoscope insertion-part diameter (see the sizing table above), with 3 mm and 6 mm cap depths.
What are the OTSC a, t and gc types?
They are the three tooth shapes: a has blunt teeth, t has small spikes, and gc has elongated spiked teeth, per Ovesco.
Related CASRAI pages
Sources
- FDA 510(k) database, K101428: accessdata.fda.gov (checked 2026-10-31)
- 21 CFR 876.4400: ecfr.gov (checked 2026-10-31)
- Ovesco, OTSC System Set: Ovesco OTSC System Set (ovesco.com/otsc-system-set/) (checked 2026-10-31)
- Ovesco, OTSCneo System Set: ovesco.com/otscneo-system (checked 2026-10-31)
