510(k) Report

510(k) · Cleared

Cleared

Modified Surgiport Disposable Trocar and Sleeve

K903419510(k) TraditionalCleared Aug 9, 19909-day reviewClass I21 CFR 878.4800

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

United States Surgical, A Division of Tyco Healthc · GDH Gouge, Surgical, General & Plastic Surgery

Cleared on Aug 9, 1990 after a 9-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 57 later devices descend from it.

Decided
Aug 9, 1990
Review
9 days
Class
Class I
Product code
GDH
Recalls
None
Predicates
0

57 later devices descend from it, 6 citing it directly.

Descendants, by year cleared 1999: 1 descendant cleared2007: 2 descendants cleared1998: 1 descendant cleared2010: 1 descendant cleared2008: 1 descendant cleared2011: 1 descendant cleared2012: 3 descendants cleared2013: 4 descendants cleared2015: 1 descendant cleared2018: 5 descendants cleared2014: 1 descendant cleared2019: 5 descendants cleared2017: 2 descendants cleared2020: 4 descendants cleared2024: 6 descendants cleared2025: 6 descendants cleared2022: 1 descendant cleared2026: 8 descendants cleared2021: 1 descendant cleared2023: 3 descendants cleared1990200020102020
  1. This deviceK903419 Modified Surgiport Disposable Trocar and SleeveUnited States Surgical, A Division of Tyco Healthc · 1990
  2. Descendant · cites it directly · 54 of its ownK063859 Surgiquest Elastomeric Optical Trocar & CannulaSurgiquest, Inc. · 2007
  3. Descendant · cites it directly · 51 of its ownK083211 Airseal Optical Trocar & Cannula SystemSurgiquest, Inc. · 2008
  4. Descendant · cites it directly · 36 of its ownK071571 Surgiquest Airseal Optical Trocar & Cannula SystemSurgiquest, Inc. · 2007
  5. Descendant · 2 generations on · 35 of its ownK103692 Sugiquest Airsealoptical Trocar & Cannula System with Integrated…Surgiquest, Inc. · 2011
  6. Descendant · 3 generations on · 27 of its ownK143404 SurgiQuest AirSeal iFS SystemSurgiquest, Inc. · 2015 · Recalled

Showing 5 of 57 descendants. See all descendants

Descendants cleared per year

1998: 11999: 12007: 22008: 12010: 12011: 12012: 32013: 42014: 12015: 12017: 22018: 52019: 52020: 42021: 12022: 12023: 32024: 62025: 62026: 8
1998high 8 (2026) · low 0 (2000)2026

Most influential descendants

Showing 5 of 57 · See all
  • K063859Surgiquest Elastomeric Optical Trocar & CannulaSurgiquest, Inc. · 2007 · cites it directly54descendants
  • K083211Airseal Optical Trocar & Cannula SystemSurgiquest, Inc. · 2008 · cites it directly51descendants
  • K071571Surgiquest Airseal Optical Trocar & Cannula SystemSurgiquest, Inc. · 2007 · cites it directly36descendants
  • K103692Sugiquest Airsealoptical Trocar & Cannula System with Integrated Insufflator Dpis 2000Surgiquest, Inc. · 2011 · 2 generations on35descendants
  • K143404SurgiQuest AirSeal iFS SystemSurgiquest, Inc. · 2015 · 3 generations on27descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K903419Modified Surgiport Disposable Trocar and SleeveUnited States Surgical, A Division of Tyco Healthc1990—
+1K063859Surgiquest Elastomeric Optical Trocar & CannulaSurgiquest, Inc.2007—
+1K083211Airseal Optical Trocar & Cannula SystemSurgiquest, Inc.2008—
+1K071571Surgiquest Airseal Optical Trocar & Cannula SystemSurgiquest, Inc.2007—
+2K103692Sugiquest Airsealoptical Trocar & Cannula System with Integrated Insufflator…Surgiquest, Inc.2011—
+3K143404SurgiQuest AirSeal iFS SystemSurgiquest, Inc.201511

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199810
199910
200720
200810
201010
201110
201230
201340
201410
201510
201720
201850
201950
202040
202110
202210
202330
202460
202560
202680
FIG. 1 — Lineage of K903419, 1990–2026Source: 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 GDH? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

  • Candidate predicates for a device like this, rankedin the report
  • Recall history across each candidate’s familyin 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? (57)

See all 57

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

NumberDeviceApplicantDecidedDescendants
K063859Surgiquest Elastomeric Optical Trocar & CannulaSurgiquest, Inc.200754
K083211Airseal Optical Trocar & Cannula SystemSurgiquest, Inc.200851
K071571Surgiquest Airseal Optical Trocar & Cannula SystemSurgiquest, Inc.200736
K100180Surgiquest Anchorport Sil KitSurgiquest, Inc.20100
K992288Auto Suture* Soft Thoracoport** Obturator and SleeveTyco Intl. (Us), Inc.19990
K974763Deroyal Industries Disposable Surgical Trocar/CannulaDeroyal Industries, Inc.19980

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, K063859 (Surgiquest, Inc., 2007) has gone furthest, with 54 descendants of its own.

How does its category compare?

All GDH devices

GDH Gouge, Surgical, General & Plastic Surgery: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · GDH

FDA has decided no GDH device since 2007.

Median 510(k) review, days · GDH

Too few GDH 510(k)s in any year since 2007 to give a median.

Recalls per year · GDH

No recall names GDH since 2007.

Adverse event reports per year · GDH

2in 2024

2007: 52009: 22010: 12011: 22012: 22013: 22014: 72015: 122016: 72017: 132018: 32019: 42020: 22021: 52022: 22023: 22024: 2
2007high 13 (2017) · low 0 (2008)2025

MAUDE reports naming product code GDH, 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
20070—05
20080—00
20090—02
20100—01
20110—02
20120—02
20130—02
20140—07
20150—012
20160—07
20170—013
20180—03
20190—04
20200—02
20210—05
20220—02
20230—02
20240—02
20250—00
20260—0—

More from United States Surgical, A Division of…

218 FDA decisions under this applicant name. See the company

  • K071406Autosuture Endo Clip Iii 5 MM Clip ApplierUnited States Surgical, A Division of Tyco Healthc · 2007
  • K071920Autosuture Absorbable Tack and ApplicatorUnited States Surgical, A Division of Tyco Healthc · 2007
  • K061288Auto Suture Endo Clip Iii 5 MM Clip ApplierUnited States Surgical, A Division of Tyco Healthc · 2006
  • K062850Autosuture Circular Eea Surgical StaplersUnited States Surgical, A Division of Tyco Healthc · 2006
  • K062326Autosuture Modified Versaport Trocar with Fixation SleeveUnited States Surgical, A Division of Tyco Healthc · 2006

Recent decisions in GDH

The GDH category page

  • K900487Modified Auto Suture Surgiport Trocar & SleeveUnited States Surgical, A Division of Tyco Healthc · 1990
  • K891901Gouges, Alexander, Bishop, LucasZinnanti Surgical Instruments, Inc. · 1989
  • K874879Auto Suture (R) Surgiport Dispos Surg Trocar/SleeveUnited States Surgical, A Division of Tyco Healthc · 1987
  • K842822Chermel Bone GougesCher Mel Corp. · 1984
  • K760850Parkes Hump Gauge Straight 7 (18 CM)V. Mueller O.V. Baxter Healthcare Corp. · 1976

https://510kreport.com/device/K903419 · printed Nov 6, 2026

Cite this page

510(k) Report. “K903419: Modified Surgiport Disposable Trocar and Sleeve.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K903419

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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