510(k) Report

510(k) · Cleared

Cleared

Reprocessed Trocars

K033591510(k) TraditionalCleared Jun 3, 2005568-day reviewClass I21 CFR 874.4420

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

Clearmedical, Inc. · KBG Trocar, Sinus

Cleared on Jun 3, 2005 as substantially equivalent to K020428 (Ethicon Endo-Surgery, Inc., 2002) and 2 other predicates after a 568-day review. Its family tree reaches back 1 generation to 2001.

Decided
Jun 3, 2005
Review
568 days
Class
Class I
Product code
KBG
Recalls
None
Predicates
3

Its longest line of descent runs back 1 generation to K011257 (2001). 3 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 2002: 1 other ancestor2001: 1 other ancestorK011257 · Endopath Non-Bladed Obturator Trocar System (5 MM) · Ethicon Endo-Surgery, Inc. · 20012000200220042006
Other ancestors, by generation 1 generation back: 2 other ancestors K011257 · Endopath Non-Bladed Obturator Trocar System (5 MM) · Ethicon Endo-Surgery, Inc. · 20010
  1. Root · 1 generation backK011257 Endopath Non-Bladed Obturator Trocar System (5 MM)Ethicon Endo-Surgery, Inc. · 2001
  2. This deviceK033591 Reprocessed TrocarsClearmedical, Inc. · 2005
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K011257Endopath Non-Bladed Obturator Trocar System (5 MM)Ethicon Endo-Surgery, Inc.2001—
0 (this device)K033591Reprocessed TrocarsClearmedical, Inc.2005—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200110
200210
FIG. 1 — Lineage of K033591, 2001–2005Source: 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 KBG? 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? (3)

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
*K020428Endopath Dilating Tip Trocar, Model #512XD
Summary page 1
…car (5mm-12mm) * Ethicon Endopath® Tristar® Blunt Tip Trocar (lOmm-12mm) The 510(k) Premarket Notification numbers for these devices are: * K020428 Endopath® Dilating Tip Trocar * K011538 Endopath® Non-Bladed Solid Obturator (with sleeve) * K011257 Endopa…
Ethicon Endo-Surgery, Inc.2002—
*K011538Endopath Non-Bladed Solid Obturator Trocar System
Summary page 1
…r® Blunt Tip Trocar (lOmm-12mm) The 510(k) Premarket Notification numbers for these devices are: * K020428 Endopath® Dilating Tip Trocar * K011538 Endopath® Non-Bladed Solid Obturator (with sleeve) * K011257 Endopath® Non-Bladed Obturator Trocar System (5mm) Devic…
Ethicon Endo-Surgery, Inc.2001—
*K011257Endopath Non-Bladed Obturator Trocar System (5 MM)
Summary page 1
…on numbers for these devices are: * K020428 Endopath® Dilating Tip Trocar * K011538 Endopath® Non-Bladed Solid Obturator (with sleeve) * K011257 Endopath® Non-Bladed Obturator Trocar System (5mm) Device description: Reprocessed endoscopic trocars consist of an obtur…
Ethicon Endo-Surgery, Inc.2001—

Also cleared against K020428: 2 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?

  • None of the 3 ancestors has a recall.
  • 2 other devices also cite its predicate K020428.

How does its category compare?

All KBG devices

KBG Trocar, Sinus: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · KBG

FDA has decided no KBG device since 2007.

Median 510(k) review, days · KBG

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

Recalls per year · KBG

No recall names KBG since 2007.

Adverse event reports per year · KBG

1in 2020

2013: 12020: 1
2007high 1 (2013) · low 0 (2007)2025

MAUDE reports naming product code KBG, 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—01
20140—00
20150—00
20160—00
20170—00
20180—00
20190—00
20200—01
20210—00
20220—00
20230—00
20240—00
20250—00
20260—0—

What is it indicated for?

The ClearMedical Reprocessed Endopath® Tristar® Blunt Tip Surgical Trocar, ClearMedical Reprocessed Endopath® Tristar® Surgical Trocar, and ClearMedical Reprocessed Endopath® Dilating Tip Trocar have application in thoracic, gynecologic laparoscopy, and other abdominal procedures to establish a path of entry for minimally invasive instruments.

Indications for use as stated in the FDA summary.

Also cleared against K020428

2 other devices cite the same predicate.

  • K081398Advanced Medical Innovations Disposable Trocars and Laparoscopic AccessoriesAdvanced Medical Innovations, Inc. · 2009
  • K043253Vanguard Reprocessed Dilating Tip and Blunt TrocarsVanguard Medical Concepts, Inc. · 20051 recall

More from Clearmedical, Inc.

14 FDA decisions under this applicant name. See the company

  • K033579Reprocessed Multiple Clip AppliersClearmedical, Inc. · 2005
  • K033578Reprocessed Reloadable Cutters, Staplers, and AppliersClearmedical, Inc. · 2005
  • K033592Reprocessed Surgical Scissors and GraspersClearmedical, Inc. · 2004
  • K033593Reprocessed Single Use Devices Biopsy ForcepsClearmedical, Inc. · 2003
  • K031416Clearmedical/Critikon Blood Pressure Cuff; Clearmedical/Welch Allyn Blood Pressure CuffClearmedical, Inc. · 2003

Recent decisions in KBG

The KBG category page

  • K013987Reprocessed Disposable TrocarsAdven Medical · 2002
  • K844186Continent Stoma System & AccessoriesChesebrough-Pond'S U.S.A. Co. · 1985

https://510kreport.com/device/K033591 · printed Nov 3, 2026

Cite this page

510(k) Report. “K033591: Reprocessed Trocars.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K033591

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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