510(k) Report

510(k) · Cleared

Cleared

Flexible Trocar Tubes

K930215510(k) TraditionalCleared Mar 16, 199361-day reviewClass II21 CFR 874.4720

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

Olympus Corp. · EWY Mediastinoscope, Surgical

Cleared on Mar 16, 1993 after a 61-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 later device descends from it.

Decided
Mar 16, 1993
Review
61 days
Class
Class II
Product code
EWY
Recalls
None
Predicates
0

1 later device descends from it, 1 citing it directly.

Descendants, by year cleared 2002: 1 descendant cleared1990200020102020
  1. This deviceK930215 Flexible Trocar TubesOlympus Corp. · 1993
  2. Descendant · cites it directly · 0 of its ownK013617 LTF-240 Pleuravideoscope, Its Accessories and Ancillary EquipmentsOlympus Optical Co., Ltd. · 2002 · Recalled

Most influential descendants

Showing 1 of 1 · See all
  • K013617LTF-240 Pleuravideoscope, Its Accessories and Ancillary EquipmentsOlympus Optical Co., Ltd. · 2002 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K930215Flexible Trocar TubesOlympus Corp.1993—
+1K013617LTF-240 Pleuravideoscope, Its Accessories and Ancillary EquipmentsOlympus Optical Co., Ltd.20022

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200210
FIG. 1 — Lineage of K930215, 1993–2002Source: 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), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in EWY? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new EWY device

  1. #1 K260003 KARL STORZ Mediastinoscopes and Instrumentsscore 11.2 · 2 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

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? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K013617LTF-240 Pleuravideoscope, Its Accessories and Ancillary EquipmentsOlympus Optical Co., Ltd.20020

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?

  • Of its descendants, K013617 (Olympus Optical Co., Ltd., 2002) has gone furthest, with 0 descendants of its own.

How does its category compare?

All EWY devices

EWY Mediastinoscope, Surgical: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · EWY

1in 2022

2015: 12016: 12017: 12021: 12022: 12026 (partial year): 1
2007high 1 (2015) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · EWY

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

Recalls per year · EWY

No recall names EWY since 2007.

Adverse event reports per year · EWY

105in 2025

2010: 12011: 12015: 22016: 122017: 22021: 42022: 92023: 972024: 992025: 105
2007high 105 (2025) · low 0 (2007)2025

MAUDE reports naming product code EWY, 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—01
20110—01
20120—00
20130—00
20140—00
20151—02
20161—012
20171—02
20180—00
20190—00
20200—00
20211—04
20221—09
20230—097
20240—099
20250—0105
20261—0—

More from Olympus Corp.

142 FDA decisions under this applicant name. See the company

  • K915402EW-10 and EW-20Olympus Corp. · 1995
  • K933200Olympus PBD StentsOlympus Corp. · 19954 recalls
  • K942338Olympus PF-8P Oes Pancreato Fiberscope and AccessoriesOlympus Corp. · 1994
  • K931763HF-Resection Electrode, Loop W/Runner Endos/AccessOlympus Corp. · 1994
  • K934835FlovalOlympus Corp. · 1994

Recent decisions in EWY

The EWY category page

  • K260003KARL STORZ Mediastinoscopes and InstrumentsKarl Storz SE & CO. KG · 2026
  • K213194HD MediastinoscopeKarl Storz Endoscopy America, Inc. · 2022
  • K202272HD MediastinoscopeKarl Storz Endoscopy America, Inc. · 2021
  • K170757Aegis Transit SystemBoston-Biomedical Associates · 2017
  • K160171Illuminated Mediastinal Access PortAegis Surgical, Ltd. · 2016

https://510kreport.com/device/K930215 · printed Nov 4, 2026

Cite this page

510(k) Report. “K930215: Flexible Trocar Tubes.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K930215

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