# Karl Storz Se & Co Kg (specification developer, TUTTLINGEN Baden-Wurttemberg, DE): 15 new FDA device listings, incl. hysteroscope (and accessories)

**Score:** 85/100

| Field | Value |
|---|---|
| Establishment | Karl Storz Se & Co Kg |
| Role | Specification developer (outsources manufacturing) |
| Establishment types | Develop Specifications But Do Not Manufacture At This Facility |
| Location | TUTTLINGEN Baden-Wurttemberg, DE |
| New listings | 15 |
| Devices | Hysteroscope (And Accessories); Endoscopic Grasping/Cutting Instrument, Non-Powered; Laparoscope, General & Plastic Surgery; Laryngoscope, Nasopharyngoscope; Pump, Portable, Aspiration (Manual Or Powered); Nasopharyngoscope (Flexible Or Rigid); System, Irrigation, Urological; Insufflator, Hysteroscopic; Arthroscope; Endoscopic Irrigation/Suction System |
| Product codes | HIH, OCZ, GCJ, EQN, BTA, EOB, LJH, HIG, HRX, OCX, OSV, HIF |
| Device classes | Class II |
| Medical specialties | Obstetrics/Gynecology, Gastroenterology, Urology, Ear, Nose, Throat, General, Plastic Surgery, Orthopedic |
| Brand names | UNIDRIVE Select System; KARL STORZ Endoscopic Accessories for Urology; KARL STORZ Trocars with Valve Seals; KARL STORZ Laryngoscopes and Accessories; ENDOMAT SELECT; UNIDRIVE SIII System; HOPKINS Telescopes for Arthroscopy; Smart Smoke Evacuation |
| First new listing | 2026-06-17 |
| Latest new listing | 2026-09-28 |
| FDA registration number | 3014342096 |
| 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.
- 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.