FDA device listing
Footed Attachment 12mm,Footed Attachment 16mm,Footed Attachment 25mm,MIS 13 cm Angled Nose Tube,MIS 13 cm Curved Nose…
FDA device listing 1254524702 · STRYKER CORP.
Key facts
| Proprietary names | Footed Attachment 12mm,Footed Attachment 16mm,Footed Attachment 25mm,MIS 13 cm Angled Nose Tube,MIS 13 cm Curved Nose Tube,MIS 13 cm Modified Curved Nose Tube,MIS 13 cm Straight Hooded Nose Tube,MIS 13 cm Straight Nose Tube,MIS 16 cm Angled Nose Tube,MIS 16 cm Curved Nose Tube,MIS 16 cm Straight Hooded Nose Tube,MIS 16 cm Straight Nose Tube,Non-Footed Attachment 8cm,Non-Footed Attachment… |
|---|---|
| Owner/operator | STRYKER CORP. |
| Owner/operator number | 1811755 |
| Premarket submissions | K191049 |
| Product codes | ERL, HBE |
| Device names | ERL - Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece, HBE - Drills, Burrs, Trephines & Accessories (Simple, Powered) |
| Device class | Class II |
| Classification regulations (21 CFR) | 874.4250, 882.4310 |
| Review panels | Ear, Nose, & Throat, Neurology |
| Registered establishments | Stryker Instruments, STRYKER MANUFACTURING KALAMAZOO |
| Establishment registrations | 3007997036, 3015967359 |
| FEI numbers | 3007997036, 3015967359 |
| Establishment operations | Complaint File Establishment, Specification Developer, Contract Manufacturer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- None 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