510(k) Report

510(k) · Cleared

Recalled · Class II · 2016

Anspach Shielded Attachment

K974025510(k) TraditionalCleared Jul 6, 1998256-day reviewClass I21 CFR 878.4820Recalls 17

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

The Anspach Effort, Inc. · GFF Bur, Surgical, General & Plastic Surgery

Cleared on Jul 6, 1998 after a 256-day review. FDA’s file for it is a 510(k) statement, which names no predicate. It has been recalled 17 times.

Decided
Jul 6, 1998
Review
256 days
Class
Class I
Product code
GFF
Recalls
17
Predicates
0

FDA’s file for it is a 510(k) statement, which names no predicate.

FIG. 1 — Lineage of K974025Source: FDA 510(k) database · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in GFF? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

  • Candidate predicates for a device like this, rankedin the report
  • Recall history across each candidate’s familyin the report
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What was it cleared against?

FDA’s file for it is a 510(k) statement, which names no predicate.

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Oct 6, 2016Class IIZ-1989-2017Under Investigation by firmSupplied Directions for Use (DFU) did not contain a recommended service interval.
Oct 6, 2016Class IIZ-1966-2017Under Investigation by firmSupplied Directions for Use (DFU) did not contain a recommended service interval.
Oct 6, 2016Class IIZ-1960-2017Under Investigation by firmSupplied Directions for Use (DFU) did not contain a recommended service interval.
Oct 6, 2016Class IIZ-1981-2017Under Investigation by firmSupplied Directions for Use (DFU) did not contain a recommended service interval.
Oct 6, 2016Class IIZ-1962-2017Under Investigation by firmSupplied Directions for Use (DFU) did not contain a recommended service interval.
Oct 6, 2016Class IIZ-1982-2017Under Investigation by firmSupplied Directions for Use (DFU) did not contain a recommended service interval.
Oct 6, 2016Class IIZ-1984-2017Under Investigation by firmSupplied Directions for Use (DFU) did not contain a recommended service interval.
Oct 6, 2016Class IIZ-1983-2017Under Investigation by firmSupplied Directions for Use (DFU) did not contain a recommended service interval.
Oct 6, 2016Class IIZ-1940-2017Under Investigation by firmSupplied Directions for Use (DFU) did not contain a recommended service interval.
Oct 6, 2016Class IIZ-1961-2017Under Investigation by firmSupplied Directions for Use (DFU) did not contain a recommended service interval.
Oct 6, 2016Class IIZ-1959-2017Under Investigation by firmSupplied Directions for Use (DFU) did not contain a recommended service interval.
Oct 6, 2016Class IIZ-1978-2017Under Investigation by firmSupplied Directions for Use (DFU) did not contain a recommended service interval.
Sep 19, 2011Class IIZ-2077-2012Device DesignAnspach Effort, Inc. Palm Beach Gardens, FL is recalling their Single Use Sterile Bone Cutting Burrs used with XMax, microMax, microMax Plus, eMax, eMax2 and eMax2 Plus High Speed Drill Systems. It is possible for the cutter to come apart.
Mar 31, 2011Class IIZ-0829-2014PendingCutter was longer than was stated on the label
Mar 31, 2011Class IIZ-0830-2014PendingCutter was longer than was stated on the label
Mar 17, 2011Not classifiedZ-3202-2011Mixed-up of materials/componentsThe Anspach Effort, Palm Beach Gardens, FL, is recalling their Single Use, Sterile Bone Cutting Burrs, Catalog #, S-1504TD, Lot #s D363039140. D323038110, D293037349 and Catalog # TURQ-434-4, Lot #s D343038845, D323038131, due to the burr…
Mar 17, 2011Not classifiedZ-3203-2011Mixed-up of materials/componentsThe Anspach Effort, Palm Beach Gardens, FL, is recalling their Single Use, Sterile Bone Cutting Burrs, Catalog #, S-1504TD, Lot #s D363039140. D323038110, D293037349 and Catalog # TURQ-434-4, Lot #s D343038845, D323038131, due to the burr…

The 5 latest of 17 recalls; the web page lists all.

No ancestor or descendant has a Class I recall.

How does its category compare?

All GFF devices

GFF Bur, Surgical, General & Plastic Surgery: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · GFF

FDA has decided no GFF device since 2007.

Median 510(k) review, days · GFF

Too few GFF 510(k)s in any year since 2007 to give a median.

Recalls per year · GFF

1in 2019

2007: 12008: 12011: 12012: 12016: 12019: 1
2007high 1 (2007) · low 0 (2009)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · GFF

72in 2025

2007: 32008: 92009: 32010: 242011: 252012: 272013: 8992014: 1162015: 1042016: 1052017: 832018: 832019: 802020: 232021: 762022: 682023: 962024: 1242025: 72
2007high 899 (2013) · low 3 (2007)2025

MAUDE reports naming product code GFF, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—13
20080—19
20090—03
20100—024
20110—125
20120—127
20130—0899
20140—0116
20150—0104
20160—1105
20170—083
20180—083
20190—180
20200—023
20210—076
20220—068
20230—096
20240—0124
20250—072
20260—0—

What is it indicated for?

Cutting and Shaping Bone.

Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.

More from The Anspach Effort, Inc.

60 FDA decisions under this applicant name. See the company

  • 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

Recent decisions in GFF

The GFF category page

  • K950449Surgical BurTransidyne General Corp. · 1995
  • K943758Surgical BurKomet Medical · 1994
  • K934583BURRSAmerican Medical Specialties, Inc. · 1994
  • K894438Micro-Aire Cutters for Midas-Rex InstrumentsMicro-Aire Surgical Instruments, Inc. · 1989
  • K890090Danek Irrigating Burr (Dib) SetDanek Medical, Inc. · 1989

https://510kreport.com/device/K974025 · printed Nov 4, 2026

Cite this page

510(k) Report. “K974025: Anspach Shielded Attachment.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K974025

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Page last updated Nov 3, 2026