510(k) Report

510(k) · Cleared

Cleared

Innerdyne Step Trocar Expandable Port, Step:

K950658510(k) TraditionalCleared May 12, 199588-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 May 12, 1995 after an 88-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 71 later devices descend from it.

Decided
May 12, 1995
Review
88 days
Class
Class II
Product code
GCJ
Recalls
None
Predicates
0

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

Descendants, by year cleared 1996: 2 descendants cleared1997: 1 descendant cleared2001: 1 descendant cleared2008: 2 descendants cleared2023: 4 descendants cleared2005: 1 descendant cleared2004: 1 descendant cleared2006: 1 descendant cleared2007: 1 descendant cleared2009: 2 descendants cleared2011: 4 descendants cleared2010: 2 descendants cleared2013: 3 descendants cleared2016: 3 descendants cleared2015: 2 descendants cleared2024: 7 descendants cleared2014: 5 descendants cleared2012: 2 descendants cleared2017: 3 descendants cleared2018: 3 descendants cleared2022: 2 descendants cleared2019: 2 descendants cleared2020: 3 descendants cleared2025: 8 descendants cleared2026: 3 descendants cleared2021: 3 descendants cleared1995200020052010201520202025
  1. This deviceK950658 Innerdyne Step Trocar Expandable Port, Step:Innerdyne, Inc. · 1995
  2. Descendant · cites it directly · 68 of its ownK961940 Innerdyne Step Trocar Expandable Port, OnestepInnerdyne, Inc. · 1996 · Recalled
  3. Descendant · 2 generations on · 67 of its ownK012539 VerastepUnited States Surgical, A Division of Tyco Healthc · 2001
  4. Descendant · 3 generations on · 59 of its ownK072814 Convenience Kit for Single-Incision Laparoscopic Surgery and Other…Covidien · 2008
  5. Descendant · 3 generations on · 58 of its ownK082619 Sils Port, Models SILSPT5, SILSPT12Covidien Lp, Formerly Registered AS United States · 2008
  6. Descendant · 4 generations on · 46 of its ownK090902 Spider Single Port Surgical Device, Support Arm Accessory, Model…Transenterix, Inc. · 2009 · Recalled

Showing 5 of 71 descendants. See all descendants

Descendants cleared per year

1996: 21997: 12001: 12004: 12005: 12006: 12007: 12008: 22009: 22010: 22011: 42012: 22013: 32014: 52015: 22016: 32017: 32018: 32019: 22020: 32021: 32022: 22023: 42024: 72025: 82026: 3
1996high 8 (2025) · low 0 (1998)2026

Most influential descendants

Showing 5 of 71 · See all
  • K961940Innerdyne Step Trocar Expandable Port, OnestepInnerdyne, Inc. · 1996 · cites it directly68descendants
  • K012539VerastepUnited States Surgical, A Division of Tyco Healthc · 2001 · 2 generations on67descendants
  • K072814Convenience Kit for Single-Incision Laparoscopic Surgery and Other Advanced Laparoscopic…Covidien · 2008 · 3 generations on59descendants
  • K082619Sils Port, Models SILSPT5, SILSPT12Covidien Lp, Formerly Registered AS United States · 2008 · 3 generations on58descendants
  • K090902Spider Single Port Surgical Device, Support Arm Accessory, Model 90001, 90002, 90003Transenterix, Inc. · 2009 · 4 generations on46descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K950658Innerdyne Step Trocar Expandable Port, Step:Innerdyne, Inc.1995—
+1K961940Innerdyne Step Trocar Expandable Port, OnestepInnerdyne, Inc.19961
+2K012539VerastepUnited States Surgical, A Division of Tyco Healthc2001—
+3K072814Convenience Kit for Single-Incision Laparoscopic Surgery and Other Advanced…Covidien2008—
+3K082619Sils Port, Models SILSPT5, SILSPT12Covidien Lp, Formerly Registered AS United States2008—
+4K090902Spider Single Port Surgical Device, Support Arm Accessory, Model 90001, 90002…Transenterix, Inc.20091

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199620
199710
200110
200410
200510
200610
200710
200820
200920
201020
201140
201220
201330
201450
201520
201630
201730
201830
201920
202030
202130
202220
202340
202470
202580
202630
FIG. 1 — Lineage of K950658, 1995–2026Source: 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 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. #1 K214046 780 nm 1688 4K Camera System, 780 nm L11 LED…score 21.4 · 21 generations · no Class I recall
  2. #2 Held for the reportin the report
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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? (71)

See all 71

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

NumberDeviceApplicantDecidedDescendants
K961940Innerdyne Step Trocar Expandable Port, OnestepInnerdyne, Inc.199668
K970754Innerdyne Step Trocar Expanable Port, Open StepInnerdyne, Inc.19970
K961430Innerdyne Step Trocar Expandable Port, MinistepInnerdyne, Inc.19960

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, K961940 (Innerdyne, Inc., 1996) has gone furthest, with 68 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

2007: 182008: 192009: 212010: 242011: 152012: 172013: 152014: 192015: 262016: 272017: 202018: 212019: 152020: 282021: 182022: 202023: 312024: 292025: 212026 (partial year): 26
2007high 31 (2023) · low 15 (2011)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · GCJ

108in 2025

2007: 42 days median2008: 73 days median2009: 85 days median2010: 122 days median2011: 113 days median2012: 88 days median2013: 93 days median2014: 90 days median2015: 76 days median2016: 99 days median2017: 77 days median2018: 88 days median2019: 60 days median2020: 61 days median2021: 116 days median2022: 103 days median2023: 109 days median2024: 90 days median2025: 108 days median2026 (partial year): 122 days median
2007high 122 (2010) · low 42 (2007)2026

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

Recalls per year · GCJ

5in 2025

2007: 122008: 162009: 62010: 302011: 92012: 12013: 7, 1 Class I2014: 22016: 52017: 12018: 12022: 12023: 12025: 52026 (partial year): 1
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

2007: 1,6392008: 1,3192009: 1,9952010: 2,6572011: 2,1332012: 1,5262013: 1,5652014: 1,7142015: 1,7102016: 2,0802017: 3,4682018: 2,5622019: 2,5782020: 2,6182021: 3,4312022: 3,9452023: 6,0022024: 6,0472025: 5,860
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
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20071842121,639
20081973161,319
2009218561,995
201024122302,657
20111511392,133
2012178811,526
201315937 (1)1,565
2014199021,714
2015267601,710
2016279952,080
2017207713,468
2018218812,562
2019156002,578
2020286102,618
20211811603,431
20222010313,945
20233110916,002
2024299006,047
20252110855,860
2026261221—

More from Innerdyne, Inc.

12 FDA decisions under this applicant name. See the company

  • K992668Innerdyne Radially Expanding Vascular Access System (Revas)Innerdyne, Inc. · 2000
  • K990854Innerdyne Radially Expanding Dilation, Red DeviceInnerdyne, Inc. · 1999
  • K990493Innerdyne Generic Radially Expanding Dilation, G-Red DeviceInnerdyne, Inc. · 1999
  • K982417Innerdyne Step Trocar Expandable Port, StepInnerdyne, Inc. · 1998
  • K980578Innerdyne Radially Expanding Vascular Access System (Heparin Coated)Innerdyne, Inc. · 1998

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https://510kreport.com/device/K950658 · printed Nov 4, 2026

Cite this page

510(k) Report. “K950658: Innerdyne Step Trocar Expandable Port, Step:.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K950658

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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