ClearanceBrief
510(k) K040186 ยท HBB Motor, Drill, Pneumatic

ANSPACH MRI SAFE SURGICAL DRILL SYSTEM

ApplicantThe Anspach Effort, Inc., Palm Beach Gardens FL, US
DecisionSubstantially Equivalent, Apr 15, 2004
ReceivedJan 27, 2004
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K040186

DateFirm and productCodeLinked 510(k)
Oct 6, 2016The Anspach Effort, Inc.
IMRI AIR CONTROL Product Usage: Pneumatic system
Terminated
HBENone listed
Oct 6, 2016The Anspach Effort, Inc.
IMRI MOTOR Product Usage: Pneumatic system
Terminated
HBENone listed
Oct 6, 2016The Anspach Effort, Inc.
IMRI CRANI-A ATTACHMENT Product Usage: Pneumatic system
Terminated
HBENone listed
Oct 6, 2016The Anspach Effort, Inc.
IMRI SHORT ATTACHMENT Product Usage: Pneumatic system
Terminated
HBENone listed
Oct 6, 2016The Anspach Effort, Inc.
IMRI SHORT HD ATTACHMENT Product Usage: Pneumatic system
Terminated
HBENone listed
Jun 25, 2014The Anspach Effort, Inc.
ANSPACH***1.85mm x 16 mm Fluted Router for MRI***Rx Only*** This device is intended to be used with Anspach Systems
Terminated
HBBNone listed
Jun 25, 2014The Anspach Effort, Inc.
ANSPACH***REF SP-3014-00***4mm Fluted Ball for MRI***Rx Only*** This device is intended to be used with Anspach Systems
Terminated
HBBNone listed

Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.