510(k) K965080 ยท ERL Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece
ANSPACH MICROMAX SYSTEM
| Applicant | The Anspach Effort, Inc., Palm Beach Gardens FL, US |
| Decision | Substantially Equivalent, Jan 10, 1997 |
| Received | Dec 19, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K965080
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 6, 2016 | The Anspach Effort, Inc. XMAX Motor (Pneumatic Drill System)
Product Usage:
Pneumatic system Terminated |
ERL | None listed |
| Oct 6, 2016 | The Anspach Effort, Inc. XMAX Motor, High Strength Hose
Product Usage:
Pneumatic system Terminated |
ERL | None listed |
| Oct 6, 2016 | The Anspach Effort, Inc. Keyless Driver
Product Usage:
Pneumatic system Terminated |
BWN | None listed |
| Jun 25, 2014 | The Anspach Effort, Inc. ANSPACH***REF 98-0034***Custom XMax Motor, Pneumatic with Hand Control and Custom Autolube III IRR Foot Pedal***Rx Only***
This device is intended to be used with Anspach Systems Terminated |
ERL | None listed |
| Jun 25, 2014 | The Anspach Effort, Inc. ANSPACH***Custom XMax Motor, Pneumatic***Rx Only***
This device is intended to be used with Anspach Systems Terminated |
ERL | None listed |
| Jun 25, 2014 | The Anspach Effort, Inc. ANSPACH***REF 98-0042***XMax Motor with Custom Hose***Rx Only***
This device is intended to be used with Anspach Systems Terminated |
ERL | None listed |
| Jan 16, 2014 | The Anspach Effort, Inc. Anspach MIA 16 (16cm Minimally Invasive Attachment), Rx Only
MIA16 attachments are intended for use with Motor Systems for cutting and shaping bones, including the spine and cranium. Terminated |
ERL | None listed |
| Jan 9, 2014 | The Anspach Effort, Inc. ***REF XMAX***XMax Handpiece***Rx Only***Manufacturer: The Anspach Effort, Inc.
Intended for cutting and shaping bone. Terminated |
ERL | None listed |
| Jan 9, 2014 | The Anspach Effort, Inc. ***REF MICROMAX***microMax Handpiece***Rx Only***Manufacturer: The Anspach Effort, Inc.
Intended for cutting and shaping bone. Terminated |
ERL | None listed |
| Feb 13, 2008 | The Anspach Effort, Inc. Anspach BlackMax Pneumatic Motor System; ENT Surgical Drill, including handpiece and Accessories Attached. All Models; Black Motors; Anspach Effort, Inc., Palm Beach FL 33410. Terminated |
ERL | None listed |
| Jul 11, 2007 | The Anspach Effort, Inc. Anspach Single Use, Sterile Bone Cutting Burrs Terminated |
HBB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.