Company · US

The Anspach Effort, Inc.

FDA 510(k) clearances and medical device recalls filed under this name, 1980 to 2022. Name variants (Inc, Corp, punctuation) are merged.

60510(k) clearances (0 in 12 months)

303recalls (0 in 12 months)

259recalls that name a 510(k)

Product codes

Code	Device	Records
HBE	Drills, Burrs, Trephines & Accessories (Simple, Powered)	111
BWN	Table And Attachments, Operating-Room	73
HBC	Motor, Drill, Electric	41
HTT	Burr, Orthopedic	22
ERL	Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece	19
GEY	Motor, Surgical Instrument, Ac-Powered	17
HBB	Motor, Drill, Pneumatic	9
HSZ	Instrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/Attachment	8
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	8
HRX	Arthroscope	5
HWE	Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment	5
GFF	Bur, Surgical, General & Plastic Surgery	4
HTC	Pliers, Surgical	3
NAV	Graft, Bypass, Coronary Artery	3
FRN	Pump, Infusion	2
FWZ	Operating Room Accessories Table Tray	2
GAD	Retractor	2
GET	Motor, Surgical Instrument, Pneumatic Powered	2
HBF	Drills, Burrs, Trephines & Accessories (Compound, Powered)	2
HTW	Bit, Drill	2

Latest 510(k) clearances

Decided	510(k)	Device and applicant	Code
May 19, 2022	K220485	Wireless Hand Control, EG1A (WIRELESS-HC), Receiver for Wireless Hand Control, EG1A (RECEIVER-HC) The Anspach Effort, Inc.	HBC
Jul 19, 2019	K183545	Anspach Helix Dissection Tools The Anspach Effort, Inc.	HBE
Mar 27, 2018	K180063	OCM-G1 Attachment The Anspach Effort, Inc.	ERL
Jan 10, 2014	K133604	ANSPACH EG1 HIGH SPEED SYSTEM, G1 ATTACHMENTS The Anspach Effort, Inc.	HBC
Dec 31, 2013	K131053	ANSPACH XMAX, EMAX2 AND EMAX2 PLUS SYSTEM WITH OTOLOGIC ATTACHMENT SYSTEM The Anspach Effort, Inc.	ERL
Dec 16, 2011	K113476	ANSPACH DISSECTION TOOLS The Anspach Effort, Inc.	HBE
Dec 22, 2008	K082637	CRANIAL PERFORATOR The Anspach Effort, Inc.	HBF
Apr 30, 2008	K080802	EMAX 2 PLUS SYSTEM, MODEL EMAX 2 PLUS MOTOR, EMAX 2 CONSOLE>FIRMWARE UPGRADE, EMAX 2 FP FOOT PEDAL The Anspach Effort, Inc.	HBE
Jan 26, 2007	K061297	ANSPACH IMRI SAFE SURGICAL DRILL SYSTEM The Anspach Effort, Inc.	HBB
Jan 16, 2007	K063688	SURGICAL IRRIGATION SYSTEM, IRRIGATION TUBE The Anspach Effort, Inc.	HWE
Dec 5, 2005	K052572	ANSPACH KNOTLESS ANCHOR The Anspach Effort, Inc.	MBI
Apr 7, 2005	K050628	ANSPACH COUPLER The Anspach Effort, Inc.	HBE
Dec 17, 2004	K042783	ANSPACH MINIMAL ACCESS SPINAL ATTACHMENT (MASA) SYSTEM The Anspach Effort, Inc.	HBE
Apr 15, 2004	K040186	ANSPACH MRI SAFE SURGICAL DRILL SYSTEM The Anspach Effort, Inc.	HBB
Mar 15, 2004	K040076	ANSPACH ADVANCED MICRO SAW ATTACHMENTS The Anspach Effort, Inc.	HBE
May 21, 2003	K030576	ANSPACH IRRIGATION PUMP AND IRRIGATION PUMP II The Anspach Effort, Inc.	FRN
Oct 21, 2002	K022907	ANSPACH POWERED KERRISON SYSTEM (PKS) The Anspach Effort, Inc.	HAD
Aug 8, 2001	K011444	ANSPACH EMAX DRILL SYSTEM The Anspach Effort, Inc.	HBC
Oct 24, 2000	K002903	ANSPACH ANGLED MICRONOSE ATTACHMENT The Anspach Effort, Inc.	HBE
Oct 21, 1998	K982991	ANSPACH ACCESS CRANIAL PERFORATOR The Anspach Effort, Inc.	HBF
Jul 13, 1998	K981688	ANSPACH SUTURE ANCHOR The Anspach Effort, Inc.	MBI
Jul 6, 1998	K974025	ANSPACH SHIELDED ATTACHMENT The Anspach Effort, Inc.	GFF
May 5, 1997	K970530	ANSPACH LUBRICATING SYSTEM II The Anspach Effort, Inc.	GEY
Feb 12, 1997	K965069	ANSPACH SUTURE ANCHOR The Anspach Effort, Inc.	MBI
Jan 10, 1997	K965080	ANSPACH MICROMAX SYSTEM The Anspach Effort, Inc.	ERL
Nov 25, 1996	K963686	ANSPACH SUTURE ANCHOR (MODIFIED) The Anspach Effort, Inc.	MBI
Nov 19, 1996	K960630	ANSPAHC SPEED REDUCER The Anspach Effort, Inc.	HBB
Jan 17, 1996	K955084	ASPACH 65,000 (MODIFICATION) The Anspach Effort, Inc.	HSZ
Jul 11, 1995	K945525	ANSPACH SUTURE ANCHOR The Anspach Effort, Inc.	HWC
Mar 21, 1994	K940535	AUTO LUBE SYSTEM The Anspach Effort, Inc.	GEY
Feb 10, 1993	K921338	ANSPACH MINI-PLATING SYSTEM The Anspach Effort, Inc.	HRS
Nov 19, 1986	K864314	EFTEKHAR RECHANNELIZATION DRILL GUIDE The Anspach Effort, Inc.	HSZ
Aug 9, 1985	K852592	CO2 FOR ARTHROSCOPY The Anspach Effort, Inc.	HRX
Mar 18, 1985	K850389	MULTIPLE OUTLET MANIFOLD The Anspach Effort, Inc.	GEY
Jun 11, 1984	K841296	TUBE TENDER The Anspach Effort, Inc.	KRI
Sep 29, 1983	K831756	ANSPACH 65,000 The Anspach Effort, Inc.	HSZ
Apr 12, 1983	K830721	WIRE TWISTERS The Anspach Effort, Inc.	HTC
Aug 16, 1982	K822065	KAM SUCKER The Anspach Effort, Inc.	KDC
May 12, 1982	K820777	MINI-MICRO ARTHROSCOPIC SCAPEL The Anspach Effort, Inc.	HRX
Apr 21, 1982	K820289	ANTHROSCOPIC SURGICAL TABLE The Anspach Effort, Inc.	FWZ
Apr 15, 1982	K820776	CANNUOATED TROCHAR The Anspach Effort, Inc.	HRX
Mar 5, 1982	K820291	KNEE SUPPORT FOR X-RAY & SURGERY The Anspach Effort, Inc.	FWZ
Mar 5, 1982	K820290	SELF RETAINING RETRACTOR FOR HAND SURG The Anspach Effort, Inc.	GAD
Mar 2, 1982	K820292	EXTRACTOR III The Anspach Effort, Inc.
Mar 1, 1982	K820293	BONE BIOPSY SET The Anspach Effort, Inc.	KNW
Feb 12, 1982	K820275	ARTHROSCOPIC HARPOON The Anspach Effort, Inc.	HRX
Aug 13, 1981	K811996	GATOR DRAPES The Anspach Effort, Inc.	KKX
Jul 20, 1981	K811717	GATOR DRAPES The Anspach Effort, Inc.	KQM
Jul 1, 1981	K811115	SUPERFLOW CANNULA FOR ARTHROS. SURGERY The Anspach Effort, Inc.
Apr 29, 1981	K811081	MEDULLARY CANAL SCRAPERS The Anspach Effort, Inc.	HTO

Newest 50 of 60.

Latest recalls

Date	Firm and product	Code	Linked 510(k)
Jan 7, 2023	The Anspach Effort, Inc. Pediatric Craniotome Ref:CRANI-P-G1 Open, Classified	HBC	K011444 K133604
Jan 7, 2023	The Anspach Effort, Inc. 6.5 cm Pediatric Craniotome Attachment. Use with XMax, microMax, and eMax Systems Ref: CRANI-P Intended for cutting and shaping bone including the spine and cranium Open, Classified	HBC	K011444 K133604
Jan 7, 2023	The Anspach Effort, Inc. 7.5 cm Large Rotating Craniotome Attachment. Use with XMax, microMax, and eMax Systems Ref: CRANI-L-R Intended for cutting and shaping bone including the spine and cranium Open, Classified	HBC	K011444 K133604
Jan 7, 2023	The Anspach Effort, Inc. Adult Craniotome, Large Ref: CRANI-L-G1 Intended for cutting and shaping bone including the spine and cranium Open, Classified	HBC	K011444 K133604
Jan 7, 2023	The Anspach Effort, Inc. 7.5 cm Large Craniotome Attachment Use with XMax, microMax, and eMax Systems. Ref: CRANI-L Intended for cutting and shaping bone including the spine and cranium Open, Classified	HBC	K011444 K133604
Jan 7, 2023	The Anspach Effort, Inc. 6.5 cm Adult Rotating Craniotome Attachment. Use with XMax, microMax, and eMax Systems Ref: CRANI-A-R intended for cutting and shaping bone including the spine and cranium Open, Classified	HBC	K011444 K133604
Jan 7, 2023	The Anspach Effort, Inc. Adult Craniotome Ref: CRANI-A-G1 Intended for cutting and shaping bone including the spine and cranium Open, Classified	HBC	K011444 K133604
Jan 7, 2023	The Anspach Effort, Inc. 6.5 cm Adult Craniotome, Thin Foot Plate Attachment. Use with XMax, microMax, and eMax Systems Ref: CRANI-A-01 intended for cutting and shaping bone including the spine and cranium by trained medica Open, Classified	HBC	K011444 K133604
Jan 7, 2023	The Anspach Effort, Inc. 6.5 cm Adult Rotating Craniotome Attachment. Use with XMax, microMax, and eMax Systems. Ref: CRANI-A Intended for cutting and shaping bone including the spine and cranium Open, Classified	HBC	K011444 K133604
Jan 11, 2018	The Anspach Effort, Inc. OSCILLATING SAW ATTACHMENT Surgical instrument motors and accessories/attachments are intended for use during surgical procedures to cut hard tissue or bone and soft tissue. Terminated	HWE	None listed
Oct 6, 2016	The Anspach Effort, Inc. 20.2cm Heavy Duty Long Heavy Short Attachment Terminated	BWN	K080802
Oct 6, 2016	The Anspach Effort, Inc. Sagittal MICRO-SAW Terminated	BWN	K080802
Oct 6, 2016	The Anspach Effort, Inc. 5.0cm Heavy Duty Short Attachment Terminated	BWN	K011444
Oct 6, 2016	The Anspach Effort, Inc. 5.0cm Short Attachment Terminated	BWN	K011444
Oct 6, 2016	The Anspach Effort, Inc. SMALL ATTACHMENT, J-LATCH Terminated	BWN	K011444
Oct 6, 2016	The Anspach Effort, Inc. SMALL ATTACHMENT, JACOBS CHUCK Terminated	BWN	K011444
Oct 6, 2016	The Anspach Effort, Inc. Reciprocating MICRO SAW Terminated	BWN	K080802
Oct 6, 2016	The Anspach Effort, Inc. 7.5cm QD Angle Attachment Terminated	BWN	K011444
Oct 6, 2016	The Anspach Effort, Inc. 8cm QD Angle Attachment Terminated	BWN	K011444
Oct 6, 2016	The Anspach Effort, Inc. 14cm QD Angle Attachment Terminated	BWN	K011444
Oct 6, 2016	The Anspach Effort, Inc. 14cm QD Angle Attachment Product Usage: Pneumatic system Terminated	BWN	K011444
Oct 6, 2016	The Anspach Effort, Inc. 10.5cm QD Angle Attachment Product Usage: Pneumatic system Terminated	BWN	None listed
Oct 6, 2016	The Anspach Effort, Inc. 11cm QD Angle Attachment Product Usage: Pneumatic system Terminated	BWN	K011444
Oct 6, 2016	The Anspach Effort, Inc. Oscillating MICRO-SAW Product Usage: Pneumatic system Terminated	BWN	K080802
Oct 6, 2016	The Anspach Effort, Inc. 90 degree Contra Angle Attachment Product Usage: Pneumatic system Terminated	BWN	K955084
Oct 6, 2016	The Anspach Effort, Inc. 45 degree Contra Angle Attachment Product Usage: Pneumatic system Terminated	BWN	K955084
Oct 6, 2016	The Anspach Effort, Inc. Otologic Curved Micro Product Usage: Pneumatic system Terminated	BWN	K131053
Oct 6, 2016	The Anspach Effort, Inc. Sagittal Saw Product Usage: Pneumatic system Terminated	BWN	K080802
Oct 6, 2016	The Anspach Effort, Inc. 16cm Minimally Invasive Attachment Product Usage: Pneumatic system Terminated	BWN	K011444
Oct 6, 2016	The Anspach Effort, Inc. 8.0CM Heavy Duty Medium Attachment Product Usage: Pneumatic system Terminated	BWN	K011444
Oct 6, 2016	The Anspach Effort, Inc. 8.0cm Medium Attachment Product Usage: Pneumatic system Terminated	BWN	K011444
Oct 6, 2016	The Anspach Effort, Inc. Minimal Access Straight Driver Product Usage: Pneumatic system Terminated	BWN	K042783
Oct 6, 2016	The Anspach Effort, Inc. Minimal Access Attachment, BLACK MAX Product Usage: Pneumatic system Terminated	BWN	None listed
Oct 6, 2016	The Anspach Effort, Inc. Minimal Access Attachment Product Usage: Pneumatic system Terminated	BWN	K042783
Oct 6, 2016	The Anspach Effort, Inc. Bearing Sleeve, 19CM Straight Taper Product Usage: Pneumatic system Terminated	BWN	None listed
Oct 6, 2016	The Anspach Effort, Inc. Bearing Sleeve, 15CM Straight Taper Product Usage: Pneumatic system Terminated	BWN	K042783
Oct 6, 2016	The Anspach Effort, Inc. Bearing Sleeve, 15CM Straight Product Usage: Pneumatic system Terminated	BWN	K042783
Oct 6, 2016	The Anspach Effort, Inc. Bearing Sleeve, 15CM Curved Product Usage: Pneumatic system Terminated	BWN	K042783
Oct 6, 2016	The Anspach Effort, Inc. Bearing Sleeve, 10CM Straight Product Usage: Pneumatic system Terminated	BWN	K042783
Oct 6, 2016	The Anspach Effort, Inc. Bearing Sleeve, 10CM Curved Product Usage: Pneumatic system Terminated	BWN	K042783
Oct 6, 2016	The Anspach Effort, Inc. 10.5cm Long Attachment Product Usage: Pneumatic system Terminated	BWN	K011444
Oct 6, 2016	The Anspach Effort, Inc. 12.4cm Heavy Duty Long Heavy Short Attachment Product Usage: Pneumatic system Terminated	BWN	K080802
Oct 6, 2016	The Anspach Effort, Inc. 10.5cm Long Attachment, Non-Tapered End Product Usage: Pneumatic system Terminated	BWN	K011444
Oct 6, 2016	The Anspach Effort, Inc. 11.0cm Long Attachment Product Usage: Pneumatic system Terminated	BWN	K011444
Oct 6, 2016	The Anspach Effort, Inc. IMRI SHORT HD ATTACHMENT Product Usage: Pneumatic system Terminated	HBE	K040186
Oct 6, 2016	The Anspach Effort, Inc. IMRI SHORT ATTACHMENT Product Usage: Pneumatic system Terminated	HBE	K040186
Oct 6, 2016	The Anspach Effort, Inc. IMRI CRANI-A ATTACHMENT Product Usage: Pneumatic system Terminated	HBE	K040186
Oct 6, 2016	The Anspach Effort, Inc. Keyless Driver Product Usage: Pneumatic system Terminated	BWN	K965080
Oct 6, 2016	The Anspach Effort, Inc. Chuck Driver System Terminated	BWN	K011444
Oct 6, 2016	The Anspach Effort, Inc. Compact Speed Reducer, 60:1 Black Max Terminated	BWN	K960630

Newest 50 of 303.

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