# Terumo BCT STERILIZATION SERVICES, Inc. (contract sterilizer, Lakewood, CO): 6 new FDA device listings, incl. endoscopic access overtube, gastroenterology-urology

**Score:** 80/100

| Field | Value |
|---|---|
| Establishment | Terumo BCT STERILIZATION SERVICES, Inc. |
| Owner / operator | Terumo BCT, INC. |
| Role | Contract sterilizer |
| Establishment types | Sterilize Medical Device for Another Party (Contract Sterilizer) |
| Location | Lakewood, CO, US |
| New listings | 6 |
| Devices | Endoscopic Access Overtube, Gastroenterology-Urology; Unit, Cryosurgical, Accessories; Catheter, Embolectomy; Dilator, Vessel, For Percutaneous Catheterization; Syringe, Piston |
| Product codes | FED, GEH, DXE, DRE, FMF |
| Device classes | Class II |
| Medical specialties | Gastroenterology, Urology, General, Plastic Surgery, Cardiovascular, General Hospital |
| Brand names | Sidecar External Working Channel (FG-1011); C2 Cryoballoon Ablation System; Needle's Eye Snare Retrieval Set; FlexTract Deflectable-Rotational Dilator Sheath Set; Merit Syringe |
| First new listing | 2026-08-21 |
| Latest new listing | 2026-08-21 |
| FDA registration number | 1724474 |
| Registration expires | 2026-12-31 |

## Why this score
- Contract manufacturer or sterilizer adding work.
- 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.