510(k) Report

FDA applicant

The Anspach Effort, Inc.

Palm Beach Gardens, FL60 decisions1980–2022257 recalls

FDA records 60 decisions for The Anspach Effort, Inc. (Palm Beach Gardens, FL) from 1980 to 2022: 60 510(k) clearances. Most are in product codes HBE (Drills, Burrs, Trephines & Accessories…) and HSZ (Instrument, Surgical, Orthopedic, Pneumatic…). Its devices cite 22 predicates, 15 of them its own earlier devices. 257 recalls are linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, general and plastic surgery panel, where it files most

How often FDA has decided The Anspach Effort, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2022

2007: 22008: 22011: 12013: 12014: 12018: 12019: 12022: 1
2007high 2 (2007) · low 0 (2009)2026

2026 so far, outlined.

Recalls per year

9in 2022

2007: 12008: 132009: 12010: 12011: 122012: 702013: 102014: 32015: 342016: 1012022: 9
2007high 101 (2016) · low 0 (2017)2026

Class I Class II/III not classified

FIG. 1 — The Anspach Effort, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like The Anspach Effort, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • HBEDrills, Burrs, Trephines & Accessories (Simple, Powered)7decisions
  • HSZInstrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/Attachment4decisions
  • MBIFastener, Fixation, Nondegradable, Soft Tissue4decisions
  • HRXArthroscope4decisions
  • HBBMotor, Drill, Pneumatic3decisions
  • GEYMotor, Surgical Instrument, Ac-Powered3decisions

Also: HBC (3), ERL (3), FWZ (2), GAD (2), HBF (2), BWN (1).

Whose devices does it build on?

Its devices cite 22 predicates; 15 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 34 times; 15 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K011444Anspach Emax Drill SystemThe Anspach Effort, Inc. · 20019cite it
  • K113476Anspach Dissection ToolsThe Anspach Effort, Inc. · 20116cite it
  • K965080Anspach Micromax SystemThe Anspach Effort, Inc. · 19974cite it
  • K030576Anspach Irrigation Pump and Irrigation Pump IIThe Anspach Effort, Inc. · 20032cite it
  • K080802Emax 2 Plus System, Model Emax 2 Plus Motor, Emax 2 Console>Firmware Upgrade, Emax 2 FP Foot PedalThe Anspach Effort, Inc. · 20082cite it
  • K831756Anspach 65,000The Anspach Effort, Inc. · 19832cite it

What has FDA decided for it lately?

  • K220485Wireless Hand Control, EG1A (WIRELESS-HC), Receiver for Wireless Hand Control, EG1A (RECEIVER-HC)The Anspach Effort, Inc. · 2022
  • K183545Anspach Helix Dissection ToolsThe Anspach Effort, Inc. · 2019
  • K180063OCM-G1 AttachmentThe Anspach Effort, Inc. · 2018
  • K133604Anspach EG1 High Speed System, G1 AttachmentsThe Anspach Effort, Inc. · 201411 recalls
  • K131053Anspach Xmax, EMAX2 and EMAX2 Plus System with Otologic Attachment SystemThe Anspach Effort, Inc. · 20133 recalls
  • K113476Anspach Dissection ToolsThe Anspach Effort, Inc. · 201139 recalls
  • K082637Cranial PerforatorThe Anspach Effort, Inc. · 2008
  • K080802Emax 2 Plus System, Model Emax 2 Plus Motor, Emax 2 Console>Firmware Upgrade, Emax 2 FP Foot PedalThe Anspach Effort, Inc. · 200835 recalls

All 60 as The Anspach Effort, Inc. →

What has been recalled?

257 recalls linked to its devices; the latest:

  • K1336046.5 cm Adult Craniotome, Thin Foot Plate Attachment. Use with XMax, microMax, and eMax…Dec 7, 2022Class II
  • K1336047.5 cm Large Craniotome Attachment Use with XMax, microMax, and eMax Systems. Ref…Dec 7, 2022Class II
  • K133604Adult Craniotome, Large Ref: CRANI-L-G1 Intended for cutting and shaping bone including…Dec 7, 2022Class II
  • K1336046.5 cm Adult Rotating Craniotome Attachment. Use with XMax, microMax, and eMax Systems.…Dec 7, 2022Class II
  • K1336047.5 cm Large Rotating Craniotome Attachment. Use with XMax, microMax, and eMax Systems…Dec 7, 2022Class II
  • K133604Pediatric Craniotome Ref:CRANI-P-G1Dec 7, 2022Class II

Other applicant names beginning “The”

FDA records each applicant name separately; these may or may not be the same firm.

Anspach Mfg., Inc. 3Anspach Fixation Systems 1