510(k) · Cleared

Cleared

Innerdyne Step Trocar Expanable Port, Open Step

K970754510(k) TraditionalCleared Apr 21, 199749-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

Innerdyne, Inc. · GCJ Laparoscope, General & Plastic Surgery

Cleared on Apr 21, 1997 as substantially equivalent to K943253 (Innerdyne Medical, Inc., 1994) and 5 other predicates after a 49-day review. Its family tree reaches back 1 generation to 1994.

Decided: Apr 21, 1997
Review: 49 days
Class: Class II
Product code: GCJ
Recalls: None
Predicates: 6

Its longest line of descent runs back 1 generation to K932020 (1994). 6 ancestors in all. No later device cites it as a predicate yet.

By dateBy generation

Root · 1 generation backK932020 Entree Blunt Tip Trocar and AdapterCore Dynamics, Inc. · 1994
This deviceK970754 Innerdyne Step Trocar Expanable Port, Open StepInnerdyne, Inc. · 1997

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K932020	Entree Blunt Tip Trocar and Adapter	Core Dynamics, Inc.	1994	—
0 (this device)	K970754	Innerdyne Step Trocar Expanable Port, Open Step	Innerdyne, Inc.	1997	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1994	3	0
1995	2	0

FIG. 1 — Lineage of K970754, 1994–1997Source: 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

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What was it cleared against? (9)

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.

Type	Number	Device	Applicant	Decided	Recalls
*	K943253	Innerdyne Step Trocar Expandable Port, S.T.E.P. Summary page 2 …adhesives, welds, and mechanical interlocks. The subject InnerDyne, Inc., Open-Step® device is substantially equivalent to the predicate InnerDyne, Inc., Step® devices (K943253, K940232, K950632, and K950658), as well as the Ethicon, ENDOPATH, Blunt-Tip Disposable Surgical Trocar, the United States Surgic…	Innerdyne Medical, Inc.	1994	—
*	K940232	Innerdyne Step Trocar Expandable Port, S.T.E.P. Summary page 2 …, welds, and mechanical interlocks. The subject InnerDyne, Inc., Open-Step® device is substantially equivalent to the predicate InnerDyne, Inc., Step® devices (K943253, K940232, K950632, and K950658), as well as the Ethicon, ENDOPATH, Blunt-Tip Disposable Surgical Trocar, the United States Surgical Corpor…	Innerdyne Medical, Inc.	1994	—
*	K950632	Innerdyne Step Trocar Expandable Port, Step Summary page 2 …and mechanical interlocks. The subject InnerDyne, Inc., Open-Step® device is substantially equivalent to the predicate InnerDyne, Inc., Step® devices (K943253, K940232, K950632, and K950658), as well as the Ethicon, ENDOPATH, Blunt-Tip Disposable Surgical Trocar, the United States Surgical Corporation, BL…	Innerdyne, Inc.	1995	—
*	K950658	Innerdyne Step Trocar Expandable Port, Step: Summary page 2 …l interlocks. The subject InnerDyne, Inc., Open-Step® device is substantially equivalent to the predicate InnerDyne, Inc., Step® devices (K943253, K940232, K950632, and K950658), as well as the Ethicon, ENDOPATH, Blunt-Tip Disposable Surgical Trocar, the United States Surgical Corporation, BLUNTPORT, Disp…	Innerdyne, Inc.	1995	—
*	K932020	Entree Blunt Tip Trocar and Adapter Summary page 2 …RT Trocar System for Open Laparoscopy, the Hasson Stable Access Cannula (SAC) of Marlow Surgical Technologies, Inc., the Core Dynamics Entree Blunt Tip Trocar & Adaptor (K932020), and the Linvatec Hasson Open Laparoscopy Cannula (K942447). The subject Open-Step® device is similar to the referenced predicat…	Core Dynamics, Inc.	1994	—
*	K942447	Hasson Open Laparoscopy Cannula Summary page 2 …ess Cannula (SAC) of Marlow Surgical Technologies, Inc., the Core Dynamics Entree Blunt Tip Trocar & Adaptor (K932020), and the Linvatec Hasson Open Laparoscopy Cannula (K942447). The subject Open-Step® device is similar to the referenced predicates in size, function, product dimensions and general indicat…	Linvatec Corp.	1994	—
*	—	Ethicon, ENDOPATH, Blunt-Tip Disposable Surgical Trocar Named without a submission number			—
*	—	United States Surgical Corporation, BLUNTPORT, Disposable VERSAPORT Trocar System for… Named without a submission number			—
*	—	Hasson Stable Access Cannula (SAC) of Marlow Surgical Technologies, Inc. Named without a submission number			—

Also cleared against K943253: 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 6 ancestors has a recall.
2 other devices also cite its predicate K943253.

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 Step® family of products are intended for use during minimally invasive surgery for temporary dilation access to the abdominal and thoracic cavities for passage of diagnostic and operative instruments into the abdominal and thoracic cavities. The device is configured to be used as either a primary or secondary stick. The subject Open-Step® device is configured to be used with the open laparoscopic surgical approach.

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/K970754 · printed Nov 4, 2026

Cite this page

510(k) Report. “K970754: Innerdyne Step Trocar Expanable Port, Open Step.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K970754

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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