The Anspach Effort, Inc.
FDA Regulatory Profile
The Anspach Effort, Inc. appears in FDA public data with 261 recalls — including 2 Class I (most serious) —, 60 510(k) clearances, 4 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-0918-2023, Class II) was initiated on December 7, 2022. Its most recent 510(k) clearance was granted on May 19, 2022.
Summary
- Total Recalls
- 261 (2 Class I)
- 510(k) Clearances
- 60
- Inspections
- 4
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-0918-2023 | Class II | Adult Craniotome Ref: CRANI-A-G1 Intended for cutting and shaping bone including the spine and | December 7, 2022 |
| Z-0921-2023 | Class II | Adult Craniotome, Large Ref: CRANI-L-G1 Intended for cutting and shaping bone including the spi | December 7, 2022 |
| Z-0924-2023 | Class II | Pediatric Craniotome Ref:CRANI-P-G1 | December 7, 2022 |
| Z-0916-2023 | Class II | 6.5 cm Adult Rotating Craniotome Attachment. Use with XMax¿, microMax, and eMax¿ Systems. Ref: CR | December 7, 2022 |
| Z-0919-2023 | Class II | 6.5 cm Adult Rotating Craniotome Attachment. Use with XMax¿, microMax, and eMax¿ Systems Ref: CRA | December 7, 2022 |
| Z-0917-2023 | Class II | 6.5 cm Adult Craniotome, Thin Foot Plate Attachment. Use with XMax¿, microMax, and eMax¿ Systems | December 7, 2022 |
| Z-0923-2023 | Class II | 6.5 cm Pediatric Craniotome Attachment. Use with XMax¿, microMax, and eMax¿ Systems Ref: CRANI-P | December 7, 2022 |
| Z-0922-2023 | Class II | 7.5 cm Large Rotating Craniotome Attachment. Use with XMax¿, microMax, and eMax¿ Systems Ref: CRANI | December 7, 2022 |
| Z-0920-2023 | Class II | 7.5 cm Large Craniotome Attachment Use with XMax¿, microMax, and eMax¿ Systems. Ref: CRANI-L | December 7, 2022 |
| Z-0398-2018 | Class II | OSCILLATING SAW ATTACHMENT Surgical instrument motors and accessories/attachments are intended fo | September 29, 2017 |
| Z-1950-2017 | Class II | eMax2 Motor Assembly Product Usage: Electric system | October 6, 2016 |
| Z-1944-2017 | Class II | XMAX Motor (Pneumatic Drill System) Product Usage: Pneumatic system | October 6, 2016 |
| Z-1939-2017 | Class II | Autolube-III with NK Product Usage: Pneumatic system | October 6, 2016 |
| Z-2004-2017 | Class II | Bearing Sleeve, 10CM Straight Product Usage: Pneumatic system | October 6, 2016 |
| Z-2007-2017 | Class II | Bearing Sleeve, 15CM Straight Taper Product Usage: Pneumatic system | October 6, 2016 |
| Z-1947-2017 | Class II | Electric Handpiece EM Hand Control Product Usage: Electric system | October 6, 2016 |
| Z-2014-2017 | Class II | 16cm Minimally Invasive Attachment Product Usage: Pneumatic system | October 6, 2016 |
| Z-1989-2017 | Class II | Large Craniotome Product Usage: Pneumatic system | October 6, 2016 |
| Z-1992-2017 | Class II | Compact Speed Reducer, 60:1 | October 6, 2016 |
| Z-1984-2017 | Class II | 8.2CM ATTACHMENT, BLACK MAX Product Usage: Pneumatic system | October 6, 2016 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K220485 | Wireless Hand Control, EG1A (WIRELESS-HC), Receiver for Wireless Hand Control, EG1A (RECEIVER-HC) | May 19, 2022 |
| K183545 | Anspach Helix Dissection Tools | July 19, 2019 |
| K180063 | OCM-G1 Attachment | March 27, 2018 |
| K133604 | ANSPACH EG1 HIGH SPEED SYSTEM, G1 ATTACHMENTS | January 10, 2014 |
| K131053 | ANSPACH XMAX, EMAX2 AND EMAX2 PLUS SYSTEM WITH OTOLOGIC ATTACHMENT SYSTEM | December 31, 2013 |
| K113476 | ANSPACH DISSECTION TOOLS | December 16, 2011 |
| K082637 | CRANIAL PERFORATOR | December 22, 2008 |
| K080802 | EMAX 2 PLUS SYSTEM, MODEL EMAX 2 PLUS MOTOR, EMAX 2 CONSOLE>FIRMWARE UPGRADE, EMAX 2 FP FOOT PEDAL | April 30, 2008 |
| K061297 | ANSPACH IMRI SAFE SURGICAL DRILL SYSTEM | January 26, 2007 |
| K063688 | SURGICAL IRRIGATION SYSTEM, IRRIGATION TUBE | January 16, 2007 |
| K052572 | ANSPACH KNOTLESS ANCHOR | December 5, 2005 |
| K050628 | ANSPACH COUPLER | April 7, 2005 |
| K042783 | ANSPACH MINIMAL ACCESS SPINAL ATTACHMENT (MASA) SYSTEM | December 17, 2004 |
| K040186 | ANSPACH MRI SAFE SURGICAL DRILL SYSTEM | April 15, 2004 |
| K040076 | ANSPACH ADVANCED MICRO SAW ATTACHMENTS | March 15, 2004 |
| K030576 | ANSPACH IRRIGATION PUMP AND IRRIGATION PUMP II | May 21, 2003 |
| K022907 | ANSPACH POWERED KERRISON SYSTEM (PKS) | October 21, 2002 |
| K011444 | ANSPACH EMAX DRILL SYSTEM | August 8, 2001 |
| K002903 | ANSPACH ANGLED MICRONOSE ATTACHMENT | October 24, 2000 |
| K982991 | ANSPACH ACCESS CRANIAL PERFORATOR | October 21, 1998 |