# Sterigenics U.S., LLC (contract sterilizer, Queensbury, NY): 68 new FDA device listings, incl. electrode, cortical

**Score:** 80/100

| Field | Value |
|---|---|
| Establishment | Sterigenics U.S., LLC |
| Owner / operator | Sotera Health LLC |
| Role | Contract sterilizer |
| Establishment types | Sterilize Medical Device for Another Party (Contract Sterilizer); Manufacture Device in the United States for Export Only |
| Location | Queensbury, NY, US |
| New listings | 68 |
| Devices | Electrode, Cortical; Powered Laser Surgical Instrument; Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass; Electrode, Depth; Screw, Fixation, Bone; Negative Pressure Wound Therapy Powered Suction Pump; Apparatus, Hemoperfusion, Sorbent; High Intensity Ultrasound System For Prostate Tissue Ablation; Resectoscope; Cystourethroscope |
| Product codes | GYC, GEX, DWF, GZL, HWC, OMP, FLD, PLP, FJL, FBO, FAS, FDC, HIH, DRA, GEI |
| Device classes | Class I, Class II, Class III |
| Medical specialties | Neurology, General, Plastic Surgery, Cardiovascular, Orthopedic, Gastroenterology, Urology, Obstetrics/Gynecology, Anesthesiology, General Hospital, Ear, Nose, Throat |
| Brand names | Subdural Electrodes: Grids, Strips, Dual-Sided, Intraoperative; PVAK -- 400 MICRON FIBER PROCEDURE KIT; AngioVac Cannula; AngioVac Cannula - Gen 4; Spencer Probe Depth Electrodes; BIORCI-HA INTERFERENCE SCREW; Delcath Hepatic CHEMOSAT® Delivery System; TULSA-PRO Ultrasound Applicator |
| First new listing | 2026-05-05 |
| Latest new listing | 2026-09-15 |
| FDA registration number | 1319639 |
| 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.