# Karl Storz Endoscopy-America, Inc. (repackager or relabeler, Auburn, MA): 14 new FDA device listings, incl. hysteroscope (and accessories)

**Score:** 75/100

| Field | Value |
|---|---|
| Establishment | Karl Storz Endoscopy-America, Inc. |
| Owner / operator | Karl Storz Se & Co Kg |
| Role | Repackager or relabeler |
| Establishment types | Repack or Relabel Medical Device |
| Location | Auburn, MA, US |
| New listings | 14 |
| Devices | Hysteroscope (And Accessories); Insufflator, Endoscopic Vessel Harvesting; Insufflator, Laparoscopic; Endoscopic Grasping/Cutting Instrument, Non-Powered; Laparoscope, General & Plastic Surgery; Pump, Portable, Aspiration (Manual Or Powered); Nasopharyngoscope (Flexible Or Rigid); System, Irrigation, Urological; Insufflator, Hysteroscopic; Arthroscope |
| Product codes | HIH, OSV, HIF, OCZ, GCJ, BTA, EOB, LJH, HIG, HRX, OCX |
| Device classes | Class II |
| Medical specialties | Obstetrics/Gynecology, Gastroenterology, Urology, General, Plastic Surgery, Ear, Nose, Throat, Orthopedic |
| Brand names | UNIDRIVE Select System; Smart Smoke Evacuation; ENDOFLATOR +; KARL STORZ Endoscopic Accessories for Urology; ENDOMAT SELECT; KARL STORZ Trocars with Valve Seals; HOPKINS Telescopes for Arthroscopy; UNIDRIVE SIII System |
| First new listing | 2026-06-17 |
| Latest new listing | 2026-09-28 |
| FDA registration number | 2020550 |
| Registration expires | 2027-12-31 |

## Why this score
- 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.