510(k) Report

510(k) · Cleared

Cleared

Snap Sternum Saw

K935517510(k) TraditionalCleared Mar 10, 1994112-day reviewClass I21 CFR 878.4820

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

Surgiquip, Inc. · HAB Saw, Powered, And Accessories

Cleared on Mar 10, 1994 after a 112-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
Mar 10, 1994
Review
112 days
Class
Class I
Product code
HAB
Recalls
None
Predicates
0

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

FIG. 1 — Lineage of K935517Source: 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 HAB? 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 HAB devices

HAB Saw, Powered, And Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · HAB

FDA has decided no HAB device since 2007.

Median 510(k) review, days · HAB

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

Recalls per year · HAB

1in 2018

2008: 32011: 22014: 12015: 22016: 12018: 1
2007high 3 (2008) · low 0 (2007)2026

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

Adverse event reports per year · HAB

476in 2025

2007: 12008: 22009: 42010: 282011: 762012: 1172013: 1812014: 1332015: 4852016: 3582017: 1,3632018: 6812019: 6762020: 1,4622021: 1,7192022: 3872023: 7342024: 7462025: 476
2007high 1,719 (2021) · low 1 (2007)2025

MAUDE reports naming product code HAB, 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—01
20080—32
20090—04
20100—028
20110—276
20120—0117
20130—0181
20140—1133
20150—2485
20160—1358
20170—01,363
20180—1681
20190—0676
20200—01,462
20210—01,719
20220—0387
20230—0734
20240—0746
20250—0476
20260—0—

More from Surgiquip, Inc.

5 FDA decisions under this applicant name. See the company

  • K935357Snap Reciprocating SawSurgiquip, Inc. · 1994
  • K935322Snap Bone ReamerSurgiquip, Inc. · 1994
  • K931769Snap Oscillating SawSurgiquip, Inc. · 1994
  • K935516Snap DrillSurgiquip, Inc. · 1994

Recent decisions in HAB

The HAB category page

  • K012320Powerpro Battery SystemLinvatec Corp. · 2001

https://510kreport.com/device/K935517 · printed Nov 6, 2026

Cite this page

510(k) Report. “K935517: Snap Sternum Saw.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K935517

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