The Anspach Effort, Inc.

FDA Regulatory Profile

Summary

Total Recalls
261 (2 Class I)
510(k) Clearances
60
Inspections
4
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-0923-2023Class II6.5 cm Pediatric Craniotome Attachment. Use with XMax¿, microMax, and eMax¿ Systems Ref: CRANI-P December 7, 2022
Z-0920-2023Class II7.5 cm Large Craniotome Attachment Use with XMax¿, microMax, and eMax¿ Systems. Ref: CRANI-L December 7, 2022
Z-0917-2023Class II6.5 cm Adult Craniotome, Thin Foot Plate Attachment. Use with XMax¿, microMax, and eMax¿ Systems December 7, 2022
Z-0919-2023Class II6.5 cm Adult Rotating Craniotome Attachment. Use with XMax¿, microMax, and eMax¿ Systems Ref: CRADecember 7, 2022
Z-0918-2023Class IIAdult Craniotome Ref: CRANI-A-G1 Intended for cutting and shaping bone including the spine and December 7, 2022
Z-0924-2023Class IIPediatric Craniotome Ref:CRANI-P-G1December 7, 2022
Z-0921-2023Class IIAdult Craniotome, Large Ref: CRANI-L-G1 Intended for cutting and shaping bone including the spiDecember 7, 2022
Z-0922-2023Class II7.5 cm Large Rotating Craniotome Attachment. Use with XMax¿, microMax, and eMax¿ Systems Ref: CRANIDecember 7, 2022
Z-0916-2023Class II6.5 cm Adult Rotating Craniotome Attachment. Use with XMax¿, microMax, and eMax¿ Systems. Ref: CRDecember 7, 2022
Z-0398-2018Class IIOSCILLATING SAW ATTACHMENT Surgical instrument motors and accessories/attachments are intended foSeptember 29, 2017
Z-2011-2017Class IIMinimal Access Straight Driver Product Usage: Pneumatic systemOctober 6, 2016
Z-1994-2017Class IIChuck Driver SystemOctober 6, 2016
Z-2015-2017Class IISagittal Saw Product Usage: Pneumatic systemOctober 6, 2016
Z-1979-2017Class IIB-SAGITTAL ASSEMBLY Product Usage: Pneumatic systemOctober 6, 2016
Z-2000-2017Class II10.5cm Long Attachment, Non-Tapered End Product Usage: Pneumatic systemOctober 6, 2016
Z-1989-2017Class IILarge Craniotome Product Usage: Pneumatic systemOctober 6, 2016
Z-2003-2017Class IIBearing Sleeve, 10CM Curved Product Usage: Pneumatic systemOctober 6, 2016
Z-1948-2017Class IIElectronic Foot Control with Direction Switch Product Usage: Electric systemOctober 6, 2016
Z-1938-2017Class IIAutolube-III with Irrigation Product Usage: Pneumatic systemOctober 6, 2016
Z-1951-2017Class IIeMax2 Hybrid Hand Control Product Usage: Electric systemOctober 6, 2016

Recent 510(k) Clearances

K-NumberDeviceDate
K220485Wireless Hand Control, EG1A (WIRELESS-HC), Receiver for Wireless Hand Control, EG1A (RECEIVER-HC)May 19, 2022
K183545Anspach Helix Dissection ToolsJuly 19, 2019
K180063OCM-G1 AttachmentMarch 27, 2018
K133604ANSPACH EG1 HIGH SPEED SYSTEM, G1 ATTACHMENTSJanuary 10, 2014
K131053ANSPACH XMAX, EMAX2 AND EMAX2 PLUS SYSTEM WITH OTOLOGIC ATTACHMENT SYSTEMDecember 31, 2013
K113476ANSPACH DISSECTION TOOLSDecember 16, 2011
K082637CRANIAL PERFORATORDecember 22, 2008
K080802EMAX 2 PLUS SYSTEM, MODEL EMAX 2 PLUS MOTOR, EMAX 2 CONSOLE>FIRMWARE UPGRADE, EMAX 2 FP FOOT PEDALApril 30, 2008
K061297ANSPACH IMRI SAFE SURGICAL DRILL SYSTEMJanuary 26, 2007
K063688SURGICAL IRRIGATION SYSTEM, IRRIGATION TUBEJanuary 16, 2007
K052572ANSPACH KNOTLESS ANCHORDecember 5, 2005
K050628ANSPACH COUPLERApril 7, 2005
K042783ANSPACH MINIMAL ACCESS SPINAL ATTACHMENT (MASA) SYSTEMDecember 17, 2004
K040186ANSPACH MRI SAFE SURGICAL DRILL SYSTEMApril 15, 2004
K040076ANSPACH ADVANCED MICRO SAW ATTACHMENTSMarch 15, 2004
K030576ANSPACH IRRIGATION PUMP AND IRRIGATION PUMP IIMay 21, 2003
K022907ANSPACH POWERED KERRISON SYSTEM (PKS)October 21, 2002
K011444ANSPACH EMAX DRILL SYSTEMAugust 8, 2001
K002903ANSPACH ANGLED MICRONOSE ATTACHMENTOctober 24, 2000
K982991ANSPACH ACCESS CRANIAL PERFORATOROctober 21, 1998