510(k) K011381 ยท ERL Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece
HUMMER IV MICRODEBRIDER SYSTEM
| Applicant | Stryker Instruments, Kalamazoo MI, US |
| Decision | Substantially Equivalent, May 25, 2001 |
| Received | May 7, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K011381
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 20, 2014 | Stryker Instruments Div. of Stryker Corporation 2.5MM Aggressive Blade
Known as a Sinuscopic Shaver Blade, this device is composed of a metal cutter and plastic drive shaft that goes into a metal housing supported by a plastic hub.
ENT Precision C Terminated |
ERL | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.