510(k) Report

510(k) · Cleared

Cleared

RE-Sharpenable Saw Blades

K940501510(k) TraditionalCleared Jun 28, 1994146-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

Adven Medical · GFA Blade, Saw, General & Plastic Surgery, Surgical

Cleared on Jun 28, 1994 after a 146-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
Jun 28, 1994
Review
146 days
Class
Class I
Product code
GFA
Recalls
None
Predicates
0

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

FIG. 1 — Lineage of K940501Source: 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 GFA? 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 GFA devices

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

FDA decisions per year · GFA

FDA has decided no GFA device since 2007.

Median 510(k) review, days · GFA

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

Recalls per year · GFA

1in 2022

2008: 72009: 12010: 22011: 12015: 22022: 1
2007high 7 (2008) · low 0 (2007)2026

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

Adverse event reports per year · GFA

381in 2025

2007: 132008: 942009: 1542010: 2212011: 2472012: 2492013: 3382014: 3782015: 3752016: 2322017: 2842018: 2542019: 3312020: 2762021: 3942022: 4422023: 3832024: 5012025: 381
2007high 501 (2024) · low 13 (2007)2025

MAUDE reports naming product code GFA, 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—013
20080—794
20090—1154
20100—2221
20110—1247
20120—0249
20130—0338
20140—0378
20150—2375
20160—0232
20170—0284
20180—0254
20190—0331
20200—0276
20210—0394
20220—1442
20230—0383
20240—0501
20250—0381
20260—0—

More from Adven Medical

6 FDA decisions under this applicant name. See the company

  • K021528Reprocessed Venodyne Sequential Compression Sleeves / WrapAdven Medical · 2002
  • K013987Reprocessed Disposable TrocarsAdven Medical · 2002
  • K012675Reprocessed Used Disposable Sequential Compression Sleeves/WrapsAdven Medical · 2002
  • K012694Reprocessed Used Disposable Arthroscopic Blades and BursAdven Medical · 2002
  • K012676Reprocessed Used, Disposable Blades, Burs, Bits and TapsAdven Medical · 2002

Recent decisions in GFA

The GFA category page

  • K971978Graft Harvesting SawbladesWrightmedicaltechnologyinc · 1997
  • K954483Stryker Sagittal Saw AttachmentStryker Instruments · 1996
  • K955229Wright Medical Technology SawbladesWrightmedicaltechnologyinc · 1996
  • K953012Disposable & Reusable Surgical Cutting ToolsBoston Surgical Products, Inc. · 1995
  • K950403Surgical Saw BladesTransidyne General Corp. · 1995

https://510kreport.com/device/K940501 · printed Nov 4, 2026

Cite this page

510(k) Report. “K940501: RE-Sharpenable Saw Blades.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K940501

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