510(k) Report

510(k) · Cleared

Cleared

Surgical Reciprocating Saw

K760957510(k) TraditionalCleared Nov 15, 197614-day reviewClass II21 CFR 872.4120

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

American Safety Equipment Corp. · DZH Saw, Bone, Ac-Powered

Cleared on Nov 15, 1976 after a 14-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
Nov 15, 1976
Review
14 days
Class
Class II
Product code
DZH
Recalls
None
Predicates
0

FDA has not posted a summary or statement for it, so its predicates are not known.

FIG. 1 — Lineage of K760957Source: 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), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in DZH? 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 has not posted a summary or statement for it, so its predicates are not known.

What descends from it?

No later submission names this one as a predicate yet.

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

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

How does its category compare?

All DZH devices

DZH Saw, Bone, Ac-Powered: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · DZH

FDA has decided no DZH device since 2007.

Median 510(k) review, days · DZH

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

Recalls per year · DZH

No recall names DZH since 2007.

Adverse event reports per year · DZH

2in 2017

2007: 62008: 52009: 42010: 32013: 12017: 2
2007high 6 (2007) · low 0 (2011)2025

MAUDE reports naming product code DZH, 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—06
20080—05
20090—04
20100—03
20110—00
20120—00
20130—01
20140—00
20150—00
20160—00
20170—02
20180—00
20190—00
20200—00
20210—00
20220—00
20230—00
20240—00
20250—00
20260—0—

More from American Safety Equipment Corp.

7 FDA decisions under this applicant name. See the company

  • K801010Kirschner WireAmerican Safety Equipment Corp. · 1980
  • K771699Cara-Stain Model 3000American Safety Equipment Corp. · 1977
  • K760956Surgical Micro DrillAmerican Safety Equipment Corp. · 1976
  • K760960Surgical Wire DriverAmerican Safety Equipment Corp. · 1976
  • K760958Surgical Oscillating SawAmerican Safety Equipment Corp. · 1976

Recent decisions in DZH

The DZH category page

  • K031793Dentatus OsciomatDentatus USA, Ltd. · 2003
  • K935443Add Line Devices (Parts) Electric Handpiece SystemsOsada Electric Co., Ltd. · 1994
  • K760958Surgical Oscillating SawAmerican Safety Equipment Corp. · 1976

https://510kreport.com/device/K760957 · printed Nov 6, 2026

Cite this page

510(k) Report. “K760957: Surgical Reciprocating Saw.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K760957

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Record history
  • FDA decision record loaded May 2, 2026
  • Page last updated Nov 3, 2026