510(k) K131053 ยท ERL Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece
ANSPACH XMAX, EMAX2 AND EMAX2 PLUS SYSTEM WITH OTOLOGIC ATTACHMENT SYSTEM
| Applicant | The Anspach Effort, Inc., Tampa FL, US |
| Decision | Substantially Equivalent, Dec 31, 2013 |
| Received | Apr 16, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K131053
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 6, 2016 | The Anspach Effort, Inc. Otologic Curved Micro
Product Usage:
Pneumatic system Terminated |
BWN | None listed |
| Mar 28, 2016 | The Anspach Effort, Inc. ANSPACH, Rx only, Otologic Curved Micro (OCCM) Diamond Ball Burr, 1.5 MM, Part # OCM7-15SD
Product Usage:
The Otologic Curved Micro (OCCM) Attachment and burrs are intended for cutting and shaping Terminated |
ERL | None listed |
| Mar 28, 2016 | The Anspach Effort, Inc. ANSPACH, Rx only, Otologic Curved Micro (OCCM) Diamond Ball Burr, 2.0 MM, Part # OCM7-2SD
Product Usage:
The Otologic Curved Micro (OCCM) Attachment and burrs are intended for cutting and shaping bon Terminated |
ERL | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.