510(k) · Cleared

Cleared

Endopath Optiview Optical Surgical Obturator and Sleeve

K990028510(k) TraditionalCleared Apr 1, 199986-day reviewClass II21 CFR 876.1500

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

Ethicon Endo-Surgery, Inc. · GCJ Laparoscope, General & Plastic Surgery

Cleared on Apr 1, 1999 after an 86-day review. The FDA summary names no predicate by number. 19 later devices descend from it.

Decided: Apr 1, 1999
Review: 86 days
Class: Class II
Product code: GCJ
Recalls: None
Predicates: 0

19 later devices descend from it, 3 citing it directly.

This deviceK990028 Endopath Optiview Optical Surgical Obturator and SleeveEthicon Endo-Surgery, Inc. · 1999
Descendant · cites it directly · 13 of its ownK032889 Optical SeparatorApplied Medical Resources · 2003
Descendant · 2 generations on · 10 of its ownK060096 Modular Trocar SystemApplied Medical Resources Corp. · 2006 · Recalled
Descendant · 3 generations on · 4 of its ownK083638 Fixation TrocarsApplied Medical Resources Corp. · 2008 · Recalled
Descendant · cites it directly · 3 of its ownK043253 Vanguard Reprocessed Dilating Tip and Blunt TrocarsVanguard Medical Concepts, Inc. · 2005 · Recalled
Descendant · 4 generations on · 2 of its ownK211577 SoftFix Balloon TrocarUnimax Medical Systems, Inc. · 2021

Showing 5 of 19 descendants. See all descendants

Descendants cleared per year

2003high 4 (2007) · low 0 (2009)2026

Most influential descendants

Showing 5 of 19 · See all

K032889Optical SeparatorApplied Medical Resources · 2003 · cites it directly13descendants
K060096Modular Trocar SystemApplied Medical Resources Corp. · 2006 · 2 generations on10descendants
K083638Fixation TrocarsApplied Medical Resources Corp. · 2008 · 3 generations on4descendants
K043253Vanguard Reprocessed Dilating Tip and Blunt TrocarsVanguard Medical Concepts, Inc. · 2005 · cites it directly3descendants
K211577SoftFix Balloon TrocarUnimax Medical Systems, Inc. · 2021 · 4 generations on2descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K990028	Endopath Optiview Optical Surgical Obturator and Sleeve	Ethicon Endo-Surgery, Inc.	1999	—
+1	K032889	Optical Separator	Applied Medical Resources	2003	—
+2	K060096	Modular Trocar System	Applied Medical Resources Corp.	2006	7
+3	K083638	Fixation Trocars	Applied Medical Resources Corp.	2008	1
+1	K043253	Vanguard Reprocessed Dilating Tip and Blunt Trocars	Vanguard Medical Concepts, Inc.	2005	1
+4	K211577	SoftFix Balloon Trocar	Unimax Medical Systems, Inc.	2021	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2003	1	0
2004	1	0
2005	1	0
2006	1	0
2007	4	0
2008	1	0
2010	1	0
2011	1	0
2013	1	0
2017	1	0
2020	1	0
2021	2	0
2023	1	0
2024	1	0
2026	1	0

FIG. 1 — Lineage of K990028, 1999–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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 GCJ? 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 GCJ device

#1 K214046 780 nm 1688 4K Camera System, 780 nm L11 LED…score 21.4 · 21 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

Get a 510(k) Report

What was it cleared against?

The FDA summary names no predicate by number.

What descends from it? (19)

See all 19

3 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K032889	Optical Separator	Applied Medical Resources	2003	13
K043253	Vanguard Reprocessed Dilating Tip and Blunt Trocars	Vanguard Medical Concepts, Inc.	2005	3
K060676	Nes Reprocessed Endoscopic Trocar	Northeast Scientific, Inc.	2007	0

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, K032889 (Applied Medical Resources, 2003) has gone furthest, with 13 descendants of its own.

How does its category compare?

All GCJ devices

GCJ Laparoscope, General & Plastic Surgery: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · GCJ

21in 2025

2007high 31 (2023) · low 15 (2011)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · GCJ

108in 2025

2007high 122 (2010) · low 42 (2007)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · GCJ

5in 2025

2007high 30 (2010) · low 0 (2015)2026

Class I (1 since 2007) Class II/III not classified

Adverse event reports per year · GCJ

5,860in 2025

2007high 6,047 (2024) · low 1,319 (2008)2025

MAUDE reports naming product code GCJ, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	18	42	12	1,639
2008	19	73	16	1,319
2009	21	85	6	1,995
2010	24	122	30	2,657
2011	15	113	9	2,133
2012	17	88	1	1,526
2013	15	93	7 (1)	1,565
2014	19	90	2	1,714
2015	26	76	0	1,710
2016	27	99	5	2,080
2017	20	77	1	3,468
2018	21	88	1	2,562
2019	15	60	0	2,578
2020	28	61	0	2,618
2021	18	116	0	3,431
2022	20	103	1	3,945
2023	31	109	1	6,002
2024	29	90	0	6,047
2025	21	108	5	5,860
2026	26	122	1	—

What is it indicated for?

The ENDOPATH® OPTIVIEW® Optical Surgical Obturator and Sleeve has applications in abdominal, gynecologic, and thoracic minimally invasive surgical procedures as well as endoscopic surgery of superficial veins and fascia of the lower extremities to establish a path of entry or to gain access through tissue planes and/or potential spaces for endoscopic instruments. The trocar may be used without visualization for primary and secondary insertions.

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

https://510kreport.com/device/K990028 · printed Nov 4, 2026

Cite this page

510(k) Report. “K990028: Endopath Optiview Optical Surgical Obturator and Sleeve.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K990028

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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