510(k) Report

510(k) · Cleared

Cleared

Comed Trogard (TM) Blunt Tip Trocar/Sleeve

K933456510(k) TraditionalCleared Nov 2, 1993111-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

Conmedcorp · GCJ Laparoscope, General & Plastic Surgery

Cleared on Nov 2, 1993 after a 111-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 3 later devices descend from it.

Decided
Nov 2, 1993
Review
111 days
Class
Class II
Product code
GCJ
Recalls
None
Predicates
0

3 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 2007: 1 descendant cleared1998: 1 descendant cleared2015: 1 descendant cleared1990200020102020
  1. This deviceK933456 Comed Trogard (TM) Blunt Tip Trocar/SleeveConmedcorp · 1993
  2. Descendant · cites it directly · 1 of its ownK073009 Oneport Surgical Trocar SystemConmed Corporation · 2007
  3. Descendant · 2 generations on · 0 of its ownK142464 EntriportConmed Corporation · 2015
  4. Descendant · cites it directly · 0 of its ownK980804 Sabre BT BLUNT0TIP Surgical TrocarEndoscopic Concepts, Inc. · 1998

Most influential descendants

Showing 3 of 3 · See all
  • K073009Oneport Surgical Trocar SystemConmed Corporation · 2007 · cites it directly1descendant
  • K142464EntriportConmed Corporation · 2015 · 2 generations on0descendants
  • K980804Sabre BT BLUNT0TIP Surgical TrocarEndoscopic Concepts, Inc. · 1998 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K933456Comed Trogard (TM) Blunt Tip Trocar/SleeveConmedcorp1993—
+1K073009Oneport Surgical Trocar SystemConmed Corporation2007—
+2K142464EntriportConmed Corporation2015—
+1K980804Sabre BT BLUNT0TIP Surgical TrocarEndoscopic Concepts, Inc.1998—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199810
200710
201510
FIG. 1 — Lineage of K933456, 1993–2015Source: 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 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?

FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

What descends from it? (3)

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

NumberDeviceApplicantDecidedDescendants
K073009Oneport Surgical Trocar SystemConmed Corporation20071
K980804Sabre BT BLUNT0TIP Surgical TrocarEndoscopic Concepts, 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, K073009 (Conmed Corporation, 2007) has gone furthest, with 1 descendant 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.

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—

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https://510kreport.com/device/K933456 · printed Nov 6, 2026

Cite this page

510(k) Report. “K933456: Comed Trogard (TM) Blunt Tip Trocar/Sleeve.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K933456

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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