510(k) Report

510(k) · Cleared

Cleared

Sterile Cytology Brushes

K820259510(k) TraditionalCleared Mar 5, 198232-day reviewClass I21 CFR 878.4800

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

American Endoscopy, Inc. · GEE Brush, Biopsy, General & Plastic Surgery

Cleared on Mar 5, 1982 after a 32-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
Mar 5, 1982
Review
32 days
Class
Class I
Product code
GEE
Recalls
None
Predicates
0

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

FIG. 1 — Lineage of K820259Source: 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.

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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 GEE devices

GEE Brush, Biopsy, General & Plastic Surgery: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · GEE

FDA has decided no GEE device since 2007.

Median 510(k) review, days · GEE

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

Recalls per year · GEE

No recall names GEE since 2007.

Adverse event reports per year · GEE

3in 2024

2019: 22020: 12021: 52022: 12024: 3
2007high 5 (2021) · low 0 (2007)2025

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

More from American Endoscopy, Inc.

19 FDA decisions under this applicant name. See the company

  • K853274American Dilatation SystemAmerican Endoscopy, Inc. · 1985
  • K841384Proxima 1 PH MonitorAmerican Endoscopy, Inc. · 1984
  • K833491Endo Bite BlockAmerican Endoscopy, Inc. · 1984
  • K840818Biopsy ForcepsAmerican Endoscopy, Inc. · 1984
  • K833859Tamponade Balloon CuffAmerican Endoscopy, Inc. · 1984

Recent decisions in GEE

The GEE category page

  • K854003Sterile Soft Tissue Biopsy NeedleCo-Medical, Inc. · 1985
  • K841008Biopsy Punch, VariousPremier Dental Products Co. · 1984
  • K822490Deflecting Cytology BrushVan-Tec, Inc. · 1982
  • K812694Whisk-RMedi-Spec · 1981
  • K801304Camloc Syringe Biopsy KitJohannah Medical Services, Inc. · 1980

https://510kreport.com/device/K820259 · printed Nov 5, 2026

Cite this page

510(k) Report. “K820259: Sterile Cytology Brushes.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K820259

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