510(k) Report

510(k) · Cleared

Cleared

Surgiquest Anchorport Sil Kit

K100180510(k) TraditionalCleared May 5, 2010104-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

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

Cleared on May 5, 2010 as substantially equivalent to K063859 (Surgiquest, Inc., 2007) and 4 other predicates after a 104-day review. Its family tree reaches back 5 generations to 1994.

Decided
May 5, 2010
Review
104 days
Class
Class II
Product code
GCJ
Recalls
None
Predicates
5

Its longest line of descent runs back 5 generations to K940232 (1994). 32 ancestors in all, the oldest K883018 (1988). No later device cites it as a predicate yet.

Other ancestors, by year cleared 2009: 1 other ancestor2007: 3 other ancestors2003: 1 other ancestor1990: 1 other ancestor2002: 1 other ancestor1998: 1 other ancestor1995: 4 other ancestors1994: 3 other ancestors2001: 2 other ancestors1999: 2 other ancestors1993: 1 other ancestor1992: 2 other ancestors1991: 1 other ancestor1988: 1 other ancestor2006: 1 other ancestor1996: 2 other ancestorsK940232 · Innerdyne Step Trocar Expandable Port, S.T.E.P. · Innerdyne Medical, Inc. · 1994K961940 · Innerdyne Step Trocar Expandable Port, Onestep · Innerdyne, Inc. · 1996 · recalledK012539 · Verastep · United States Surgical, A Division of Tyco Healthc · 2001K072814 · Convenience Kit for Single-Incision Laparoscopic Surgery and Other Advanced Laparoscopic Procedures · Covidien · 2008K082619 · Sils Port, Models SILSPT5, SILSPT12 · Covidien Lp, Formerly Registered AS United States · 2008198519901995200020052010
Other ancestors, by generation 1 generation back: 4 other ancestors2 generations back: 5 other ancestors3 generations back: 12 other ancestors4 generations back: 5 other ancestors5 generations back: 1 other ancestor K082619 · Sils Port, Models SILSPT5, SILSPT12 · Covidien Lp, Formerly Registered AS United States · 2008K072814 · Convenience Kit for Single-Incision Laparoscopic Surgery and Other Advanced Laparoscopic Procedures · Covidien · 2008K012539 · Verastep · United States Surgical, A Division of Tyco Healthc · 2001K961940 · Innerdyne Step Trocar Expandable Port, Onestep · Innerdyne, Inc. · 1996 · recalledK940232 · Innerdyne Step Trocar Expandable Port, S.T.E.P. · Innerdyne Medical, Inc. · 1994−50
  1. Root · 5 generations backK940232 Innerdyne Step Trocar Expandable Port, S.T.E.P.Innerdyne Medical, Inc. · 1994
  2. 4 generations backK961940 Innerdyne Step Trocar Expandable Port, OnestepInnerdyne, Inc. · 1996 · Recalled
  3. 3 generations backK012539 VerastepUnited States Surgical, A Division of Tyco Healthc · 2001
  4. 2 generations backK072814 Convenience Kit for Single-Incision Laparoscopic Surgery and Other…Covidien · 2008
  5. 1 generation backK082619 Sils Port, Models SILSPT5, SILSPT12Covidien Lp, Formerly Registered AS United States · 2008
  6. This deviceK100180 Surgiquest Anchorport Sil KitSurgiquest, Inc. · 2010
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−5K940232Innerdyne Step Trocar Expandable Port, S.T.E.P.Innerdyne Medical, Inc.1994—
−4K961940Innerdyne Step Trocar Expandable Port, OnestepInnerdyne, Inc.19961
−3K012539VerastepUnited States Surgical, A Division of Tyco Healthc2001—
−2K072814Convenience Kit for Single-Incision Laparoscopic Surgery and Other Advanced…Covidien2008—
−1K082619Sils Port, Models SILSPT5, SILSPT12Covidien Lp, Formerly Registered AS United States2008—
0 (this device)K100180Surgiquest Anchorport Sil KitSurgiquest, Inc.2010—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198810
199010
199110
199220
199310
199430
199540
199620
199810
199920
200120
200210
200310
200610
200730
200910
FIG. 1 — Lineage of K100180, 1994–2010Source: 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
Get a 510(k) Report

What was it cleared against? (5)

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
*K063859Surgiquest Elastomeric Optical Trocar & Cannula
Summary page 1
…AnchorPort'V SIL Kit PREDICATE DEVICE SurgiQuest Elastomeric Optical trocar & Cannula SurgiQuest, Inc. (Orange, CT) K 063859 GeIPOrNT System Applied Medical (Rancho Santa Margarita, CA)…
Surgiquest, Inc.2007—
*K090275Gelport Single Incision Access System
Summary page 1
…e, CT) K 063859 GeIPOrNT System Applied Medical (Rancho Santa Margarita, CA) k090275 SILSTM Port Covidien LP (North Haven, CT) K0 82619…
Applied Medical Resources Corp.2009—
*K082619Sils Port, Models SILSPT5, SILSPT12
Summary page 1
…ancho Santa Margarita, CA) k090275 SILSTM Port Covidien LP (North Haven, CT) K0 82619 SurgiportTm Blunt Tip Trocar U.S. Surgical Corp. (Norwalk, CT)…
Covidien Lp, Formerly Registered AS United States2008—
*K903419Modified Surgiport Disposable Trocar and Sleeve
Summary page 1
…CT) K0 82619 SurgiportTm Blunt Tip Trocar U.S. Surgical Corp. (Norwalk, CT) K903419 EndoPath IIITM Trocar System Ethicon Endo-Surgery, Inc. (Cincinnati, OH)…
United States Surgical, A Division of Tyco Healthc1990—
*K032676Endopath Bladeless Trocar, Endopath Blunt Tip Trocar, Endopath Dilating Tip Trocar
Summary page 1
…K903419 EndoPath IIITM Trocar System Ethicon Endo-Surgery, Inc. (Cincinnati, OH) K032676 DEVICE DESCRIPTION The subject is a surgical trocar and cannula kit is composed of biosafe materials.…
Ethicon Endo-Surgery, Inc.20036

Also cleared against K063859: 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?

  • The line of descent spans 16 years and passes through 6 companies; a new generation was cleared every 2.2 years on median.
  • 3 of the 32 ancestors have a recall of any class.
  • 2 other devices also cite its predicate K063859.

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. 2010, 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 AnchorPort® SIL Kit has applications in abdominal minimally invasive surgical procedures and specifically where the surgeon will make a single skin incision in order to facilitate the use of multiple trocars to establish a port of entry for operating endoscopic instruments.

Indications for use as stated in the FDA summary.

Also cleared against K063859

2 other devices cite the same predicate.

  • K083211Airseal Optical Trocar & Cannula SystemSurgiquest, Inc. · 2008
  • K071571Surgiquest Airseal Optical Trocar & Cannula SystemSurgiquest, Inc. · 2007

More from Surgiquest, Inc.

9 FDA decisions under this applicant name. See the company

  • K143404SurgiQuest AirSeal iFS SystemSurgiquest, Inc. · 201511 recalls
  • K132169Surgiquest Airseal IfsSurgiquest, Inc. · 2013
  • K121336Modified Surgiquest Airseal Optical Trocar & Cannula System with Integrated Insufflator Dpis 2000Surgiquest, Inc. · 2012
  • K103692Sugiquest Airsealoptical Trocar & Cannula System with Integrated Insufflator Dpis 2000Surgiquest, Inc. · 2011
  • K092504Surgiquest Airseal Optical Trocar and Cannula SystemSurgiquest, Inc. · 2009

Recent decisions in GCJ

The GCJ category page

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https://510kreport.com/device/K100180 · printed Nov 6, 2026

Cite this page

510(k) Report. “K100180: Surgiquest Anchorport Sil Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K100180

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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