510(k) Report

510(k) · Cleared

Cleared

Versaport Bladeless Low Profile Trocar Model NB3SHFLP, NB5SHFLP, NB5STFLP

K100548510(k) SpecialCleared Apr 26, 201059-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

Covidien Lp, Formerly Registered AS Tyco Healthcar · GCJ Laparoscope, General & Plastic Surgery

Cleared on Apr 26, 2010 after a 59-day review. The FDA summary names its predicate without a number. 16 later devices descend from it.

Decided
Apr 26, 2010
Review
59 days
Class
Class II
Product code
GCJ
Recalls
None
Predicates
0

16 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2011: 1 descendant cleared2016: 5 descendants cleared2023: 1 descendant cleared2013: 1 descendant cleared2022: 1 descendant cleared2015: 1 descendant cleared2017: 1 descendant cleared2020: 1 descendant cleared2014: 1 descendant cleared2026: 2 descendants cleared2025: 1 descendant cleared2010201520202025
  1. This deviceK100548 Versaport Bladeless Low Profile Trocar Model NB3SHFLP, NB5SHFLP…Covidien Lp, Formerly Registered AS Tyco Healthcar · 2010
  2. Descendant · cites it directly · 15 of its ownK112349 Versaport V2 Bladeless Optiical Trocar and/or Versaport Bladeless…Covidien, Formerly US Surgical A Divison of Tyco H · 2011 · Recalled
  3. Descendant · 2 generations on · 11 of its ownK130435 Versaport V2 Bladeless Optical TrocarCovidien, Formerly US Surgical A Divison of Tyco H · 2013
  4. Descendant · 3 generations on · 7 of its ownK151548 VersaOne Bladed Trocar, VersaOne Bladeless TrocarCovidien · 2015
  5. Descendant · 3 generations on · 1 of its ownK163654 VersaOne fascial closure system bladed trocar, VersaOne fascial…Covidien, LLC · 2017
  6. Descendant · 3 generations on · 1 of its ownK160564 TroClose1200Gordian Surgical, Ltd. · 2016 · Recalled

Showing 5 of 16 descendants. See all descendants

Descendants cleared per year

2011: 12013: 12014: 12015: 12016: 52017: 12020: 12022: 12023: 12025: 12026: 2
2011high 5 (2016) · low 0 (2012)2026

Most influential descendants

Showing 5 of 16 · See all
  • K112349Versaport V2 Bladeless Optiical Trocar and/or Versaport Bladeless Optical TrocarCovidien, Formerly US Surgical A Divison of Tyco H · 2011 · cites it directly15descendants
  • K130435Versaport V2 Bladeless Optical TrocarCovidien, Formerly US Surgical A Divison of Tyco H · 2013 · 2 generations on11descendants
  • K151548VersaOne Bladed Trocar, VersaOne Bladeless TrocarCovidien · 2015 · 3 generations on7descendants
  • K163654VersaOne fascial closure system bladed trocar, VersaOne fascial closure system bladeless…Covidien, LLC · 2017 · 3 generations on1descendant
  • K160564TroClose1200Gordian Surgical, Ltd. · 2016 · 3 generations on1descendant
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K100548Versaport Bladeless Low Profile Trocar Model NB3SHFLP, NB5SHFLP, NB5STFLPCovidien Lp, Formerly Registered AS Tyco Healthcar2010—
+1K112349Versaport V2 Bladeless Optiical Trocar and/or Versaport Bladeless Optical TrocarCovidien, Formerly US Surgical A Divison of Tyco H20116
+2K130435Versaport V2 Bladeless Optical TrocarCovidien, Formerly US Surgical A Divison of Tyco H2013—
+3K151548VersaOne Bladed Trocar, VersaOne Bladeless TrocarCovidien2015—
+3K163654VersaOne fascial closure system bladed trocar, VersaOne fascial closure system…Covidien, LLC2017—
+3K160564TroClose1200Gordian Surgical, Ltd.20161

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201110
201310
201410
201510
201650
201710
202010
202210
202310
202510
202620
FIG. 1 — Lineage of K100548, 2010–2026Source: 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? (1)

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
*—Versaport Bladeless Trocar
Named without a submission number
—

What descends from it? (16)

See all 16

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K112349Versaport V2 Bladeless Optiical Trocar and/or Versaport Bladeless Optical TrocarCovidien, Formerly US Surgical A Divison of Tyco H201115

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, K112349 (Covidien, Formerly US Surgical A Divison of Tyco H, 2011) has gone furthest, with 15 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. 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 Versaport Bladeless Trocar is intended for use in a variety of gynecologic, general, thoracic and urologic endoscopic procedures to create and maintain a port of entry.

Indications for use as stated in the FDA summary.

More from Covidien Lp, Formerly Registered AS…

4 FDA decisions under this applicant name. See the company

  • K093372Sils Port Model SILSPT15Covidien Lp, Formerly Registered AS Tyco Healthcar · 2009
  • K082296Copa AmdCovidien Lp, Formerly Registered AS Tyco Healthcar · 2009
  • K073122Monoject Hypodermic Needle, Model 250, 30 Gauge Hypodermic NeedleCovidien Lp, Formerly Registered AS Tyco Healthcar · 2007

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The GCJ category page

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https://510kreport.com/device/K100548 · printed Nov 6, 2026

Cite this page

510(k) Report. “K100548: Versaport Bladeless Low Profile Trocar Model NB3SHFLP, NB5SHFLP, NB5STFLP.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K100548

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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