510(k) Report

510(k) · Cleared

Cleared

Auto Suture (R) Surgiport Dispos Surg Trocar/Sleeve

K874879510(k) TraditionalCleared Dec 17, 198738-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 Dec 17, 1987 after a 38-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 later device descends from it.

Decided
Dec 17, 1987
Review
38 days
Class
Class I
Product code
GDH
Recalls
None
Predicates
0

1 later device descends from it, 1 citing it directly.

Descendants, by year cleared 1998: 1 descendant cleared1990200020102020
  1. This deviceK874879 Auto Suture (R) Surgiport Dispos Surg Trocar/SleeveUnited States Surgical, A Division of Tyco Healthc · 1987
  2. Descendant · cites it directly · 0 of its ownK974763 Deroyal Industries Disposable Surgical Trocar/CannulaDeroyal Industries, Inc. · 1998

Most influential descendants

Showing 1 of 1 · See all
  • K974763Deroyal Industries Disposable Surgical Trocar/CannulaDeroyal Industries, Inc. · 1998 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K874879Auto Suture (R) Surgiport Dispos Surg Trocar/SleeveUnited States Surgical, A Division of Tyco Healthc1987—
+1K974763Deroyal Industries Disposable Surgical Trocar/CannulaDeroyal Industries, Inc.1998—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199810
FIG. 1 — Lineage of K874879, 1987–1998Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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
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? (1)

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

NumberDeviceApplicantDecidedDescendants
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, K974763 (Deroyal Industries, Inc., 1998) has gone furthest, with 0 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

  • K903419Modified Surgiport Disposable Trocar and SleeveUnited States Surgical, A Division of Tyco Healthc · 1990
  • K900487Modified Auto Suture Surgiport Trocar & SleeveUnited States Surgical, A Division of Tyco Healthc · 1990
  • K891901Gouges, Alexander, Bishop, LucasZinnanti Surgical Instruments, Inc. · 1989
  • 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/K874879 · printed Nov 4, 2026

Cite this page

510(k) Report. “K874879: Auto Suture (R) Surgiport Dispos Surg Trocar/Sleeve.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K874879

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026