# Karl Storz Endoscopy-America, Inc. (contract manufacturer, Auburn, MA): 15 new FDA device listings, incl. system, irrigation, urological

**Score:** 90/100

| Field | Value |
|---|---|
| Establishment | Karl Storz Endoscopy-America, Inc. |
| Owner / operator | Karl Storz Se & Co Kg |
| Role | Contract manufacturer |
| Establishment types | Manufacture Medical Device for Another Party (Contract Manufacturer); Repack or Relabel Medical Device |
| Location | Auburn, MA, US |
| New listings | 15 |
| Devices | System, Irrigation, Urological; Nasopharyngoscope (Flexible Or Rigid); Pump, Portable, Aspiration (Manual Or Powered); Insufflator, Hysteroscopic; Arthroscope; Endoscopic Irrigation/Suction System; Coagulator-Cutter, Endoscopic, Unipolar (And Accessories); Endoscopic Grasping/Cutting Instrument, Non-Powered; Hysteroscope (And Accessories); Laparoscope, General & Plastic Surgery |
| Product codes | LJH, EOB, BTA, HIG, HRX, OCX, KNF, OCZ, HIH, GCJ, OSV, HIF |
| Device classes | Class II |
| Medical specialties | Gastroenterology, Urology, Ear, Nose, Throat, General, Plastic Surgery, Obstetrics/Gynecology, Orthopedic |
| Brand names | ENDOMAT SELECT; SUPRALOOP; KARL STORZ Endoscopic Accessories for Urology; UNIDRIVE Select System; UNIDRIVE SIII System; KARL STORZ Trocars with Valve Seals; Smart Smoke Evacuation; ENDOFLATOR + |
| First new listing | 2026-06-17 |
| Latest new listing | 2026-10-08 |
| FDA registration number | 2020550 |
| Registration expires | 2027-12-31 |

## 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.
- 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: 2026-11-04T21:52:36.524Z.
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.