FDA device listing
Spirotome
FDA device listing 1447887454 · Bioncise NV
Key facts
| Proprietary names | Spirotome |
|---|---|
| Owner/operator | Bioncise NV |
| Owner/operator number | 10028101 |
| Premarket submissions | K190378 |
| Product codes | HCZ, HHK, KNW |
| Device names | HCZ - Forceps, Surgical, Gynecological, HHK - Curette, Suction, Endometrial (And Accessories), KNW - Instrument, Biopsy |
| Device class | Class II |
| Classification regulations (21 CFR) | 876.1075, 884.1175, 884.4530 |
| Review panels | Gastroenterology & Urology, Obstetrics/Gynecology |
| Registered establishments | BIONCISE NV |
| Establishment registrations | 3007513241 |
| FEI numbers | 3007513241 |
| Establishment operations | Manufacturer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- 1–9 UDI devices (GUDID) under the same submission
- 1–9 Device listings citing the same submission
- Yes Premarket submission listed
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device listings
Establishments that make or process devices for the U.S. market must list each device with the FDA. A listing records the device's proprietary names, product codes and premarket submission, and every registered establishment that handles it.
Source: U.S. Food and Drug Administration (FDA), Establishment Registration and Device Listing database