# Merit Medical Systems, Inc. (manufacturer, South Jordan, UT): 7 new FDA device listings, incl. endoscopic access overtube, gastroenterology-urology

**Score:** 85/100

| Field | Value |
|---|---|
| Establishment | Merit Medical Systems, Inc. |
| Role | Manufacturer |
| Establishment types | Manufacture Medical Device |
| Location | South Jordan, UT, US |
| New listings | 7 |
| Devices | Endoscopic Access Overtube, Gastroenterology-Urology; Dilator, Vessel, For Percutaneous Catheterization; Catheter, Embolectomy; Unit, Cryosurgical, Accessories; Endoscopic Irrigation/Suction System |
| Product codes | FED, DRE, DXE, GEH, OCX |
| Device classes | Class II |
| Medical specialties | Gastroenterology, Urology, Cardiovascular, General, Plastic Surgery |
| Brand names | Sidecar External Working Channel (FG-1011); Curved Inner Femoral Sheath and Curved Introducer Sheath Set - Femoral.; Needle's Eye Snare Retrieval Set; C2 Cryoballoon Ablation System; C2 Cryoballoon Endogrip; FlexTract Deflectable-Rotational Dilator Sheath Set |
| First new listing | 2026-05-08 |
| Latest new listing | 2026-08-20 |
| FDA registration number | 1721504 |
| Registration expires | 2027-12-31 |

## Why this score
- Brings its own devices to market: buys manufacturing, sterilization and QMS help.
- Class II or III devices: QMS and regulatory demands.
- Several new listings at once.
- U.S. establishment.

Source: openFDA device registration and listing endpoint (U.S. Food and Drug Administration) (https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/rl.cfm). Last refreshed: 2026-10-28T20:51:27.468Z.
From the openFDA device registration and listing data, refreshed weekly. A listing shows a device an establishment says it makes or handles for the U.S. market; it is not FDA clearance or approval. Contact persons and street addresses are not stored. Verify in the FDA Establishment Registration and Device Listing database.