510(k) Report

510(k) · Cleared

Cleared

Funnel Trocar

K992324510(k) TraditionalCleared Aug 19, 199938-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

Patton Medical Corp. · GCJ Laparoscope, General & Plastic Surgery

Cleared on Aug 19, 1999 as substantially equivalent to K943976 (Endoscopic Concepts, Inc., 1994) and 5 other predicates after a 38-day review. Its family tree reaches back 1 generation to 1990. 2 later devices descend from it.

Decided
Aug 19, 1999
Review
38 days
Class
Class II
Product code
GCJ
Recalls
None
Predicates
6

Its longest line of descent runs back 1 generation to K901407 (1990). 6 ancestors in all. 2 later devices descend from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1995: 3 other ancestors1994: 1 other ancestor1991: 1 other ancestor2008: 1 descendant cleared2013: 1 descendant clearedK901407 · Core Disposable Trocars · Core Dynamics, Inc. · 19901990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 5 other ancestors 1 generation forward: 1 descendant2 generations forward: 1 descendant K901407 · Core Disposable Trocars · Core Dynamics, Inc. · 19900
  1. Root · 1 generation backK901407 Core Disposable TrocarsCore Dynamics, Inc. · 1990
  2. This deviceK992324 Funnel TrocarPatton Medical Corp. · 1999
  3. Descendant · cites it directly · 1 of its ownK080161 Pasport Optical Trocar, Vortex Seal, Blunt Tip Trocar, Shielded…Patton Surgical Corp. · 2008
  4. Descendant · 2 generations on · 0 of its ownK130826 Passport Robotic Reducer Cap; Passport Stopcock with Rotating Male…Stryker Endoscopy · 2013

Most influential descendants

Showing 2 of 2 · See all
  • K080161Pasport Optical Trocar, Vortex Seal, Blunt Tip Trocar, Shielded Trocar, Cannula AnchorPatton Surgical Corp. · 2008 · cites it directly1descendant
  • K130826Passport Robotic Reducer Cap; Passport Stopcock with Rotating Male LuerStryker Endoscopy · 2013 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K901407Core Disposable TrocarsCore Dynamics, Inc.1990—
0 (this device)K992324Funnel TrocarPatton Medical Corp.1999—
+1K080161Pasport Optical Trocar, Vortex Seal, Blunt Tip Trocar, Shielded Trocar…Patton Surgical Corp.2008—
+2K130826Passport Robotic Reducer Cap; Passport Stopcock with Rotating Male LuerStryker Endoscopy2013—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199110
199410
199530

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200810
201310
FIG. 1 — Lineage of K992324, 1990–2013Source: 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? (6)

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
*K943976Sabre Ultimate Shielded Trocar
Summary page 1
…isposable Surgical Trocar/Cannula Classification: Laparoscope, General & Plastic Surgery, § 876.1500, Class i Predicate Devices: Sabre Ultimate Shielded Trocar System (K943976), manufactured by Endoscopic Concepts Incorporated, 11 Forest Park Drive, Mendon, MA 01756. Laparoscopic Trocar (K901407, K91181…
Endoscopic Concepts, Inc.1994—
*K901407Core Disposable Trocars
Summary page 1
…Devices: Sabre Ultimate Shielded Trocar System (K943976), manufactured by Endoscopic Concepts Incorporated, 11 Forest Park Drive, Mendon, MA 01756. Laparoscopic Trocar (K901407, K911813, K950457, K953409, K953903), manufactured by Core Dynamics, Inc., P.O. Box 16351, Jacksonville, FL 32245. Description o…
Core Dynamics, Inc.1990—
*K911813Entree Cannula
Summary page 1
…Sabre Ultimate Shielded Trocar System (K943976), manufactured by Endoscopic Concepts Incorporated, 11 Forest Park Drive, Mendon, MA 01756. Laparoscopic Trocar (K901407, K911813, K950457, K953409, K953903), manufactured by Core Dynamics, Inc., P.O. Box 16351, Jacksonville, FL 32245. Description of Device:…
Core Dynamics, Inc.1991—
*K950457Cannual and Trocar, Superpubic
Summary page 1
…imate Shielded Trocar System (K943976), manufactured by Endoscopic Concepts Incorporated, 11 Forest Park Drive, Mendon, MA 01756. Laparoscopic Trocar (K901407, K911813, K950457, K953409, K953903), manufactured by Core Dynamics, Inc., P.O. Box 16351, Jacksonville, FL 32245. Description of Device: The Fun…
Core Dynamics, Inc.1995—
*K953409Laparoscopic Trocar
Summary page 1
…elded Trocar System (K943976), manufactured by Endoscopic Concepts Incorporated, 11 Forest Park Drive, Mendon, MA 01756. Laparoscopic Trocar (K901407, K911813, K950457, K953409, K953903), manufactured by Core Dynamics, Inc., P.O. Box 16351, Jacksonville, FL 32245. Description of Device: The Funnel Troca…
Core Dynamics, Inc.1995—
*K953903Laparoscopic Trocar Obturator, 5MM, 10/11MM, 10/12MM
Summary page 1
…car System (K943976), manufactured by Endoscopic Concepts Incorporated, 11 Forest Park Drive, Mendon, MA 01756. Laparoscopic Trocar (K901407, K911813, K950457, K953409, K953903), manufactured by Core Dynamics, Inc., P.O. Box 16351, Jacksonville, FL 32245. Description of Device: The Funnel Trocar™ is a d…
Core Dynamics, Inc.1995—

Also cleared against K943976: 1 other device →

What descends from it? (2)

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

NumberDeviceApplicantDecidedDescendants
K080161Pasport Optical Trocar, Vortex Seal, Blunt Tip Trocar, Shielded Trocar, Cannula AnchorPatton Surgical Corp.20081

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?

  • None of the 6 ancestors has a recall.
  • Of its descendants, K080161 (Patton Surgical Corp., 2008) has gone furthest, with 1 descendant of its own.
  • 1 other device also cites its predicate K943976.

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.

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 Funnel Trocar™ is an access device for laparoscopic procedures. The new instrument creates and maintains a passageway for laparoscopic instruments during a variety of general,

gynecologic, thoracic, and urological procedures.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

Also cleared against K943976

1 other device cites the same predicate.

  • K980804Sabre BT BLUNT0TIP Surgical TrocarEndoscopic Concepts, Inc. · 1998

More from Patton Medical Corp.

4 FDA decisions under this applicant name. See the company

  • K012279Patton TripolPatton Medical Corp. · 2002
  • K012150Patton Endo-BagPatton Medical Corp. · 2001
  • K991963Patton SpeculumPatton Medical Corp. · 1999

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The GCJ category page

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https://510kreport.com/device/K992324 · printed Nov 5, 2026

Cite this page

510(k) Report. “K992324: Funnel Trocar.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K992324

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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