510(k) Report

510(k) · Cleared

Cleared

Ecotract Adjustable Wound Protector/Retractor

K010711510(k) TraditionalCleared May 22, 200174-day reviewClass II21 CFR 878.4370

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

Advanced Surgical Concepts (Asc) · KKX Drape, Surgical, Antimicrobial

Cleared on May 22, 2001 after a 74-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 70 later devices descend from it.

Decided
May 22, 2001
Review
74 days
Class
Class II
Product code
KKX
Recalls
None
Predicates
0

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

Descendants, by year cleared 2007: 2 descendants cleared2008: 2 descendants cleared2010: 4 descendants cleared2015: 2 descendants cleared2024: 7 descendants cleared2009: 3 descendants cleared2011: 6 descendants cleared2016: 3 descendants cleared2022: 2 descendants cleared2012: 4 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 cleared200020052010201520202025
  1. This deviceK010711 Ecotract Adjustable Wound Protector/RetractorAdvanced Surgical Concepts (Asc) · 2001
  2. Descendant · cites it directly · 69 of its ownK070158 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

Showing 5 of 70 descendants. See all descendants

Descendants cleared per year

2007: 22008: 22009: 32010: 42011: 62012: 42013: 22014: 52015: 22016: 32017: 32018: 32019: 22020: 32021: 32022: 22023: 32024: 72025: 82026: 3
2007high 8 (2025) · low 2 (2007)2026

Most influential descendants

Showing 5 of 70 · See all
  • K070158R-Port Laparoscopic Access DeviceAdvanced Surgical Concepts · 2007 · cites it directly69descendants
  • 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
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K010711Ecotract Adjustable Wound Protector/RetractorAdvanced Surgical Concepts (Asc)2001—
+1K070158R-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

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200720
200820
200930
201040
201160
201240
201320
201450
201520
201630
201730
201830
201920
202030
202130
202220
202330
202470
202580
202630
FIG. 1 — Lineage of K010711, 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), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in KKX? 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 KKX device

  1. #1 K222578 3M™ Ioban™ CHG Chlorhexidine Gluconate Incise…score 5.7 · 2 generations · no Class I recall
  2. #2 Held for the reportin the report
Get a 510(k) Report

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? (70)

See all 70

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

NumberDeviceApplicantDecidedDescendants
K070158R-Port Laparoscopic Access DeviceAdvanced Surgical Concepts200769
K073170R-Port II Laparoscopic Access DeviceAdvanced Surgical Concepts200768
K073719Asc Triport Laparoscopic Access DeviceAdvanced Surgical Concepts200813

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, K070158 (Advanced Surgical Concepts, 2007) has gone furthest, with 69 descendants of its own.

How does its category compare?

All KKX devices

KKX Drape, Surgical, Antimicrobial: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · KKX

2in 2023

2007: 42008: 52009: 52010: 82011: 42012: 22013: 32014: 62015: 22017: 12020: 12021: 12023: 2
2007high 8 (2010) · low 0 (2016)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · KKX

182in 2014

2007: 181 days median2008: 164 days median2009: 114 days median2010: 107 days median2011: 147 days median2013: 227 days median2014: 182 days median
2007high 227 (2013) · low 107 (2010)2026

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

Recalls per year · KKX

2in 2024

2007: 12010: 12011: 12012: 12013: 72014: 7, 7 Class I2016: 42024: 22026 (partial year): 2
2007high 7 (2013) · low 0 (2008)2026

Class I (7 since 2007) Class II/III not classified

Adverse event reports per year · KKX

24in 2025

2007: 242008: 242009: 272010: 252011: 572012: 402013: 632014: 282015: 332016: 562017: 302018: 322019: 412020: 162021: 412022: 192023: 322024: 192025: 24
2007high 63 (2013) · low 16 (2020)2025

MAUDE reports naming product code KKX, 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
20074181124
20085164024
20095114027
20108107125
20114147157
20122—140
20133227763
201461827 (7)28
20152—033
20160—456
20171—030
20180—032
20190—041
20201—016
20211—041
20220—019
20232—032
20240—219
20250—024
20260—2—

More from Advanced Surgical Concepts (Asc)

4 FDA decisions under this applicant name. See the company

  • K011183Omniport Hand and Instrument Access DeviceAdvanced Surgical Concepts (Asc) · 2001
  • K002013OmniportAdvanced Surgical Concepts (Asc) · 2000
  • K993544Space-or RetractorAdvanced Surgical Concepts (Asc) · 1999

Recent decisions in KKX

The KKX category page

  • K230645BeneHold™ Surgical Incise Drape with CHG antimicrobial IIAvery Dennison Medical, Ltd. · 2023
  • K2225783M™ Ioban™ CHG Chlorhexidine Gluconate Incise Drape (contains 2% w/w CHG)3M Company · 2023
  • K202208BeneHold Surgical Incise Drape with CHG antimicrobialAvery Dennison Belgie Bvba · 2021
  • K200238ControlRad Sterile CoverControlrad, Inc. · 2020
  • K163556MediClear PreOpCovalontechnologies, Inc. · 2017

https://510kreport.com/device/K010711 · printed Nov 4, 2026

Cite this page

510(k) Report. “K010711: Ecotract Adjustable Wound Protector/Retractor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K010711

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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