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Short answer: Endoscopic suturing means placing sutures, or suture-based anchors, through tissue using an endoscope-mounted or endoscope-passed device, instead of through an open or laparoscopic incision. In the United States, FDA does not treat it as one product category. Its classification database lists separate product codes by intended use, and all three codes covered here are Class 2 (openFDA and FDA Product Classification, checked 2026-10-31). This page is general product and regulatory information, not medical advice.
Definition and scope
Endoscopic suturing covers devices that let a clinician bring tissue together with suture from inside the gastrointestinal tract. The device is used through an endoscope rather than through an abdominal wall incision. That is the dividing line from the instruments on our laparoscopic instruments guide, which are introduced through ports in the abdominal wall.
This page stays at the level of product and records. It does not describe how a procedure is performed, and it does not discuss clinical results.
How it is used in practice
One manufacturer example shows the general shape of a system. Boston Scientific describes its OverStitch NXT as an endoscopic suturing system designed for use on single-channel gastroscopes and compatible with a wide range of gastroscopes across multiple manufacturers. It describes tissue approximation by placement of anchor-sutures for endoscopic bariatric procedures (Boston Scientific OverStitch NXT product page, EU site, checked 2026-10-31). The instructions for use are published separately by the manufacturer, so any compatibility or labelling question should be answered from the IFU for the exact product.
The practical point for a supply or records reader is that a suturing system is tied to a specific scope setup. It is not a loose accessory that fits any endoscope.
How FDA classifies endoscopic suturing devices
FDA assigns a three-letter product code to each device type, and the code is tied to a regulation number and a class. Three codes cover endoscopic suturing and tissue approximation. The table below reproduces what the FDA records state, nothing more (openFDA device classification endpoint, data last updated 2026-10-19; FDA Product Classification pages for ODE and QTD, checked 2026-10-31).
| Product code | FDA device name | Regulation number | Class | Implant flag | FDA definition |
|---|---|---|---|---|---|
| ODE | Endoscopic suture/plication system, gastroesophageal reflux disease (GERD) | 876.1500 | 2 | Yes | Indicated for chronic gastroesophageal reflux disease (GERD); approximates tissue with sutures or plicates tissue with an implant. |
| QTD | Endoscopic suturing device for altering gastric anatomy for weight loss | 876.5983 | 2 | Yes | Uses suturing to approximate gastric tissue to restrict stomach volume, for the intended purpose of weight loss. |
| OCW | Endoscopic tissue approximation device | 876.1500 | 2 | No | To aid in endoscopically placing sutures, staples, clips, and other fastening tools through tissue. |
Two things stand out in these records. First, the code follows the stated intended use. ODE and QTD name a specific indication (reflux, weight loss), while OCW describes a general tissue approximation aid that also covers staples and clips. Second, the two indication-specific codes sit under different regulation numbers (876.1500 and 876.5983) even though both are Class 2.
Types and related concepts
Endoscopic suturing sits next to other ways of closing or fastening tissue. These sibling topics have their own CASRAI guides:
- endoloop guide, a related loop-based device with its own FDA classification.
- Hemoclip, for clip-based tissue fastening.
- Surgical stapler types, for staple-based fastening.
- Medical forceps types, the grasping instruments that often sit alongside these devices.
Where it matters for labs, clinics and supply records
The FDA records support a short checklist for anyone cataloguing or comparing endoscopic suturing products. It is a records checklist, not purchasing advice.
- Match the product code to the stated use. A device cleared under a weight-loss code (QTD) and one under a reflux code (ODE) are different FDA device types with different regulation numbers.
- Note the regulation number and class. For the codes above, ODE and OCW share 876.1500 and QTD uses 876.5983; all are Class 2.
- Check the implant flag. FDA flags ODE and QTD as implants and OCW as not an implant.
- Record the scope compatibility statement. The manufacturer example above is described as designed for single-channel gastroscopes, so the endoscope in use is part of the product record.
- Keep the manufacturer’s IFU location with the record. The IFU, not a summary page, is the source for labelling and use.
- Handle the scope itself separately. Reprocessing of the endoscope is covered in the endoscope reprocessing guide.
Common misunderstandings
- “Endoscopic suturing is one FDA category.” It is not. The records above show distinct codes and regulation numbers by intended use.
- “A suturing system fits any endoscope.” The manufacturer example describes a defined scope type, so compatibility is a product-level statement.
FAQ
What is endoscopic suturing?
It is the placing of sutures or suture anchors through tissue with a device used through an endoscope, rather than through an incision. FDA’s records describe such devices by intended use, such as approximating gastric tissue or aiding in placing sutures, staples and clips.
What product codes does FDA use for endoscopic suturing devices?
The FDA classification records include ODE (GERD), QTD (weight loss) and OCW (general endoscopic tissue approximation). All three are listed as Class 2 (checked 2026-10-31).
How is endoscopic suturing different from laparoscopic suturing?
The route differs. Endoscopic devices are used through an endoscope inside the digestive tract, while laparoscopic instruments are introduced through ports in the abdominal wall.
Sources
- openFDA device classification endpoint, product codes ODE, QTD and OCW, https://api.fda.gov/device/classification.json (data last updated 2026-10-19; checked 2026-10-31).
- FDA Product Classification database, code ODE: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPCD/classification.cfm?id=ODE (checked 2026-10-31).
- FDA Product Classification database, code QTD: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPCD/classification.cfm?id=QTD (checked 2026-10-31).
- FDA Product Classification database, code OCW: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPCD/classification.cfm?id=OCW (checked 2026-10-31).
- Boston Scientific, OverStitch NXT product page (EU): https://www.bostonscientific.com/en-EU/products/bariatric-endoscopy/overstitch-nxt.html (checked 2026-10-31).
