# Boston Scientific Corporation (specification developer, Marlborough, MA): 9 new FDA device listings, incl. ureteroscope and accessories, flexible/rigid

**Score:** 95/100

| Field | Value |
|---|---|
| Establishment | Boston Scientific Corporation |
| Role | Specification developer (outsources manufacturing) |
| Establishment types | Develop Specifications But Do Not Manufacture At This Facility; Complaint File Establishment per 21 CFR 820.198 |
| Location | Marlborough, MA, US |
| New listings | 9 |
| Devices | Ureteroscope And Accessories, Flexible/Rigid; Unit, Electrosurgical, Endoscopic (With Or Without Accessories); Endoscopic Ultrasound System, Gastroenterology-Urology; Hydrogel Spacer; Kit, Nephroscope; Cystoscope And Accessories, Flexible/Rigid; Endoscopic Access Overtube, Gastroenterology-Urology |
| Product codes | FGB, KNS, ODG, OVB, FGA, FAJ, FED |
| Device classes | Class II |
| Medical specialties | Gastroenterology, Urology, Radiology |
| First new listing | 2026-06-22 |
| Latest new listing | 2026-10-16 |
| FDA registration number | 3005099803 |
| 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.
- Listed in the last 45 days.

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.