510(k) Report

510(k) · Cleared

Cleared

R-Port Laparoscopic Access Device

K070158510(k) TraditionalCleared Aug 23, 2007218-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

Advanced Surgical Concepts · GCJ Laparoscope, General & Plastic Surgery

Cleared on Aug 23, 2007 as substantially equivalent to K062209 (Ethicon Endo-Surgery, LLC, 2006) and 3 other predicates after a 218-day review. Its family tree reaches back 1 generation to 2001. 69 later devices descend from it.

Decided
Aug 23, 2007
Review
218 days
Class
Class II
Product code
GCJ
Recalls
None
Predicates
4

Its longest line of descent runs back 1 generation to K010007 (2001). 4 ancestors in all. 69 later devices descend from it, 3 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2006: 1 other ancestor2003: 1 other ancestor2001: 1 other ancestor2010: 4 descendants cleared2008: 2 descendants cleared2007: 1 descendant cleared2015: 2 descendants cleared2024: 7 descendants cleared2009: 3 descendants cleared2011: 6 descendants cleared2012: 4 descendants cleared2016: 3 descendants cleared2022: 2 descendants cleared2013: 2 descendants cleared2014: 5 descendants cleared2017: 3 descendants cleared2018: 3 descendants cleared2019: 2 descendants cleared2020: 3 descendants cleared2025: 8 descendants cleared2023: 3 descendants cleared2026: 3 descendants cleared2021: 3 descendants clearedK010007 · Adapt Laparoscopic Port & Adapt Reducer Cap · Taut, Inc. · 2001 · recalled200020052010201520202025
Other ancestors, by generationDescendants, by generation 1 generation back: 3 other ancestors 1 generation forward: 3 descendants2 generations forward: 6 descendants3 generations forward: 11 descendants4 generations forward: 7 descendants5 generations forward: 7 descendants6 generations forward: 5 descendants7 generations forward: 4 descendants8 generations forward: 6 descendants9 generations forward: 5 descendants10 generations forward: 4 descendants11 generations forward: 3 descendants12 generations forward: 3 descendants13 generations forward: 5 descendants K010007 · Adapt Laparoscopic Port & Adapt Reducer Cap · Taut, Inc. · 2001 · recalled0+5+10
  1. Root · 1 generation backK010007 Adapt Laparoscopic Port & Adapt Reducer CapTaut, Inc. · 2001 · Recalled
  2. This deviceK070158 R-Port Laparoscopic Access DeviceAdvanced Surgical Concepts · 2007
  3. Descendant · cites it directly · 68 of its ownK073170 R-Port II Laparoscopic Access DeviceAdvanced Surgical Concepts · 2007
  4. Descendant · 2 generations on · 58 of its ownK082619 Sils Port, Models SILSPT5, SILSPT12Covidien Lp, Formerly Registered AS United States · 2008
  5. Descendant · 3 generations on · 46 of its ownK090902 Spider Single Port Surgical Device, Support Arm Accessory, Model…Transenterix, Inc. · 2009 · Recalled
  6. Descendant · 3 generations on · 43 of its ownK112208 Intutive Surgical DA Vinci Single Site Instruments and AccessoriesIntuitive Surgical, Inc. · 2011 · Recalled
  7. Descendant · 4 generations on · 42 of its ownK120215 Single-Site Medium-Large Clip Applier, Single-Site Cadiere Grasper…Intuitive Surgical, Inc. · 2012 · Recalled

Showing 5 of 69 descendants. See all descendants

Descendants cleared per year

2007: 12008: 22009: 32010: 42011: 62012: 42013: 22014: 52015: 22016: 32017: 32018: 32019: 22020: 32021: 32022: 22023: 32024: 72025: 82026: 3
2007high 8 (2025) · low 1 (2007)2026

Most influential descendants

Showing 5 of 69 · See all
  • K073170R-Port II Laparoscopic Access DeviceAdvanced Surgical Concepts · 2007 · cites it directly68descendants
  • K082619Sils Port, Models SILSPT5, SILSPT12Covidien Lp, Formerly Registered AS United States · 2008 · 2 generations on58descendants
  • K090902Spider Single Port Surgical Device, Support Arm Accessory, Model 90001, 90002, 90003Transenterix, Inc. · 2009 · 3 generations on46descendants
  • K112208Intutive Surgical DA Vinci Single Site Instruments and AccessoriesIntuitive Surgical, Inc. · 2011 · 3 generations on43descendants
  • K120215Single-Site Medium-Large Clip Applier, Single-Site Cadiere Grasper, Single-Site Fundus…Intuitive Surgical, Inc. · 2012 · 4 generations on42descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K010007Adapt Laparoscopic Port & Adapt Reducer CapTaut, Inc.20013
0 (this device)K070158R-Port Laparoscopic Access DeviceAdvanced Surgical Concepts2007—
+1K073170R-Port II Laparoscopic Access DeviceAdvanced Surgical Concepts2007—
+2K082619Sils Port, Models SILSPT5, SILSPT12Covidien Lp, Formerly Registered AS United States2008—
+3K090902Spider Single Port Surgical Device, Support Arm Accessory, Model 90001, 90002…Transenterix, Inc.20091
+3K112208Intutive Surgical DA Vinci Single Site Instruments and AccessoriesIntuitive Surgical, Inc.201112
+4K120215Single-Site Medium-Large Clip Applier, Single-Site Cadiere Grasper…Intuitive Surgical, Inc.20123

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200110
200310
200610

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200710
200820
200930
201040
201160
201240
201320
201450
201520
201630
201730
201830
201920
202030
202130
202220
202330
202470
202580
202630
FIG. 1 — Lineage of K070158, 2001–2026Source: 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), 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. #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
  3. #3 Held for the reportin the report
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What was it cleared against? (4)

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
*K062209Basx Bladeless Trocar
Summary page 1
…Classification Name: Endoscopic Accessory and Surgical Retractor 3. PREDICATE DEVICES * Ethicon Endo-Surgery LLC BASX Bladeless Trocar subject of K062209 * Taut Inc. ADAPt Laparoscopic Port and Accessory subject of K010007 * Ethicon Endopath ILL Trocar System subject o…
Ethicon Endo-Surgery, LLC2006—
*K010007Adapt Laparoscopic Port & Adapt Reducer Cap
Summary page 1
…3. PREDICATE DEVICES * Ethicon Endo-Surgery LLC BASX Bladeless Trocar subject of K062209 * Taut Inc. ADAPt Laparoscopic Port and Accessory subject of K010007 * Ethicon Endopath ILL Trocar System subject ofK032676 * ASC Ecotract Device subject of K010711 4. DEVICE DESCR…
Taut, Inc.20013
*K032676Endopath Bladeless Trocar, Endopath Blunt Tip Trocar, Endopath Dilating Tip Trocar
Summary page 1
…ASX Bladeless Trocar subject of K062209 * Taut Inc. ADAPt Laparoscopic Port and Accessory subject of K010007 * Ethicon Endopath ILL Trocar System subject ofK032676 * ASC Ecotract Device subject of K010711 4. DEVICE DESCRIPTION The ASC R-Port Laparoscopic Access Device (ASC R…
Ethicon Endo-Surgery, Inc.20036
*K010711Ecotract Adjustable Wound Protector/Retractor
Summary page 1
…Taut Inc. ADAPt Laparoscopic Port and Accessory subject of K010007 * Ethicon Endopath ILL Trocar System subject ofK032676 * ASC Ecotract Device subject of K010711 4. DEVICE DESCRIPTION The ASC R-Port Laparoscopic Access Device (ASC R-Port) is a laparoscopic instrument access…
Advanced Surgical Concepts (Asc)2001—

What descends from it? (69)

See all 69

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

NumberDeviceApplicantDecidedDescendants
K073170R-Port II Laparoscopic Access DeviceAdvanced Surgical Concepts200768
K073719Asc Triport Laparoscopic Access DeviceAdvanced Surgical Concepts200813
K101794Asc Triport Laparoscopic Access Device Model TPRT-02-01 (WA58000T), Asc Quadport…Advanced Surgical Concepts20104

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?

  • 2 of the 4 ancestors have a recall of any class.
  • Of its descendants, K073170 (Advanced Surgical Concepts, 2007) 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. 2007, this device’s year, is highlighted.

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—

What is it indicated for?

The ASC R-Port Laparoscopic Access Device is intended for use as an endoscopic instrument or camera port during minimally invasive abdominal laparoscopic surgery.

Indications for use as stated in the FDA summary.

More from Advanced Surgical Concepts

9 FDA decisions under this applicant name. See the company

  • K232701Guardenia (GAR-1)Advanced Surgical Concepts · 2023
  • K192898PneumoLinerAdvanced Surgical Concepts · 20201 recall
  • K121309Asc Quadport + Laparoscopic Access DeviceAdvanced Surgical Concepts · 2012
  • K111407Triport, Triport+, TRIPORT15, QuadportAdvanced Surgical Concepts · 2012
  • K110004Asc Triport+ Laparoscopic Access DeviceAdvanced Surgical Concepts · 2011

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The GCJ category page

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https://510kreport.com/device/K070158 · printed Nov 4, 2026

Cite this page

510(k) Report. “K070158: R-Port Laparoscopic Access Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K070158

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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