510(k) Report

510(k) · Cleared

Cleared

Oes Urology

K950719510(k) TraditionalCleared Dec 11, 1996664-day reviewClass II21 CFR 876.4770

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

Olympus America, Inc. · EZO Urethrotome

Cleared on Dec 11, 1996 as substantially equivalent to K790071 (Olympus Corp., 1979) and 2 other predicates after a 664-day review. Its family tree reaches back 1 generation to 1979.

Decided
Dec 11, 1996
Review
664 days
Class
Class II
Product code
EZO
Recalls
None
Predicates
3

Its longest line of descent runs back 1 generation to K790071 (1979). 3 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 1992: 2 other ancestorsK790071 · Endoscope and Accessories · Olympus Corp. · 1979 · recalled19751980198519901995
Other ancestors, by generation 1 generation back: 2 other ancestors K790071 · Endoscope and Accessories · Olympus Corp. · 1979 · recalled0
  1. Root · 1 generation backK790071 Endoscope and AccessoriesOlympus Corp. · 1979 · Recalled
  2. This deviceK950719 Oes UrologyOlympus America, Inc. · 1996
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K790071Endoscope and AccessoriesOlympus Corp.19796
0 (this device)K950719Oes UrologyOlympus America, Inc.1996—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199220
FIG. 1 — Lineage of K950719, 1979–1996Source: FDA 510(k) summaries, read by 510(k) Report · 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 summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in EZO? 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
Get a 510(k) Report

What was it cleared against? (4)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

TypeNumberDeviceApplicantDecidedRecalls
*K790071Endoscope and Accessories
Summary page 1
…ome System DEC 1 | 1996 Common/Usual Name: Endoscopic Accessories for Urology Classification Name: Endoscope and Accessories Predicate Devices: Olympus Urology System (K790071) Olympus Infant Resectoscope and Accessories (K904940) Olympus Flexible & Rigid Urethrotome System (K904339) Karl Storz Endosco…
Olympus Corp.19796
*K904940Olympus Infant Resectoscope and Accessories
Summary page 1
…ccessories for Urology Classification Name: Endoscope and Accessories Predicate Devices: Olympus Urology System (K790071) Olympus Infant Resectoscope and Accessories (K904940) Olympus Flexible & Rigid Urethrotome System (K904339) Karl Storz Endoscopes & Accessories for Urology (Unknown). Submitted By:…
Olympus Corp.1992—
*K904939Flexible and Rigid Ureterotome System
Our OCR of the scanned summary read K904339, which is not a number in FDA’s lists. Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Olympus Flexible & Rigid Urethrotome System”.
Olympus Corp.19921
*—Karl Storz Endoscopes & Accessories for Urology
Named without a submission number
—

Also cleared against K790071: 4 other devices →

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.

What does this lineage say?

  • 2 of the 3 ancestors have a recall of any class.
  • 4 other devices also cite its predicate K790071.

How does its category compare?

All EZO devices

EZO Urethrotome: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · EZO

FDA has decided no EZO device since 2007.

Median 510(k) review, days · EZO

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

Recalls per year · EZO

1in 2010

2010: 1
2007high 1 (2010) · low 0 (2007)2026

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

Adverse event reports per year · EZO

1in 2024

2007: 32008: 12009: 32010: 42011: 42012: 52013: 22015: 12017: 12018: 32020: 12021: 12022: 22023: 72024: 1
2007high 7 (2023) · low 0 (2014)2025

MAUDE reports naming product code EZO, 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—03
20080—01
20090—03
20100—14
20110—04
20120—05
20130—02
20140—00
20150—01
20160—00
20170—01
20180—03
20190—00
20200—01
20210—01
20220—02
20230—07
20240—01
20250—00
20260—0—

What is it indicated for?

Olympus 00216 Otis Urethrotome and 02160 Replacement Blade are intended to be used for endoscopic and treatment within the urethra in adults.

Olympus 02161 Otis Urethrotome and 02162 Replacement Blade are intended to be used for endoscopic treatment within the urethra in children.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

Also cleared against K790071

4 other devices cite the same predicate.

  • K093665Endo SmartcapByrne Medical, Inc. · 20097 recalls
  • K992141Olympus Working Element for ProbesOlympus Winter & Ibe GmbH · 1999
  • K990237Trocar System According to HassonOlympus America, Inc. · 1999
  • K983811Unipolar Optical Biopsy ForcepsOlympus Winter & Ibe GmbH · 1998

More from Olympus America, Inc.

149 FDA decisions under this applicant name. See the company

  • K111788Endoeye HD IIOlympus America, Inc. · 20122 recalls
  • K081615Olympus Cea - Carcinoembryonic AntigenOlympus America, Inc. · 2009
  • K073489Olympus Iga ReagentOlympus America, Inc. · 20081 recall
  • K073490Olympus Igg ReagentOlympus America, Inc. · 2008
  • K073487Olympus Igm ReagentOlympus America, Inc. · 20081 recall

Recent decisions in EZO

The EZO category page

  • K000905Urethrotome 8667.XXX and 8670.XXXRichard Wolf Medical Instruments Corp. · 2000
  • K945686Karl Storz Knives, CurettesKARL STORZ Endoscopy-America, Inc. · 1995
  • K934730Karl Storz Endoscopic Cold Knife BladesKARL STORZ Endoscopy-America, Inc. · 1994
  • K904939Flexible and Rigid Ureterotome SystemOlympus Corp. · 19921 recall

https://510kreport.com/device/K950719 · printed Nov 6, 2026

Cite this page

510(k) Report. “K950719: Oes Urology.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K950719

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