510(k) Report

510(k) · Cleared

Recalled · Class II · 2023

Carter-Thomason Needle-Point Suture Passer Instrument Set

K980123510(k) TraditionalCleared Mar 9, 199854-day reviewClass II21 CFR 876.1500Recalls 1

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

Louisville Laboratories, Inc. · GCJ Laparoscope, General & Plastic Surgery

Cleared on Mar 9, 1998 after a 54-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 7 later devices descend from it. It has been recalled once.

Decided
Mar 9, 1998
Review
54 days
Class
Class II
Product code
GCJ
Recalls
1
Predicates
0

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

Descendants, by year cleared 2024: 2 descendants cleared2014: 1 descendant cleared2006: 1 descendant cleared2018: 1 descendant cleared2026: 1 descendant cleared1999: 1 descendant cleared1995200020052010201520202025
  1. This deviceK980123 Carter-Thomason Needle-Point Suture Passer Instrument SetLouisville Laboratories, Inc. · 1998
  2. Descendant · cites it directly · 1 of its ownK180701 SafePath Suturing SystemSafepath Medical, Inc. · 2018
  3. Descendant · cites it directly · 0 of its ownK260197 Shogun Axis™ Fascial Closure System (1018S, 1018B, 1218S, 1218B…Suzhou Shenyun Medical Equipment Co., Ltd. · 2026
  4. Descendant · 2 generations on · 0 of its ownK222944 SafePath Sulturing System-Silk Suture, SafePath Sulturing System…Safepath Medical, Inc. · 2024
  5. Descendant · cites it directly · 0 of its ownK241111 AMT Suture PasserApplied Medical Technology, Inc. · 2024
  6. Descendant · cites it directly · 0 of its ownK133414 Reprocessed Closure SystemSterilmed, Inc. · 2014 · Recalled

Showing 5 of 7 descendants. See all descendants

Descendants cleared per year

1999: 12006: 12014: 12018: 12024: 22026: 1
1999high 2 (2024) · low 0 (2000)2026

Most influential descendants

Showing 5 of 7 · See all
  • K180701SafePath Suturing SystemSafepath Medical, Inc. · 2018 · cites it directly1descendant
  • K260197Shogun Axis™ Fascial Closure System (1018S, 1018B, 1218S, 1218B, 1518S, 1518B)Suzhou Shenyun Medical Equipment Co., Ltd. · 2026 · cites it directly0descendants
  • K222944SafePath Sulturing System-Silk Suture, SafePath Sulturing System Polyamide Suture…Safepath Medical, Inc. · 2024 · 2 generations on0descendants
  • K241111AMT Suture PasserApplied Medical Technology, Inc. · 2024 · cites it directly0descendants
  • K133414Reprocessed Closure SystemSterilmed, Inc. · 2014 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K980123Carter-Thomason Needle-Point Suture Passer Instrument SetLouisville Laboratories, Inc.1998—
+1K180701SafePath Suturing SystemSafepath Medical, Inc.2018—
+1K260197Shogun Axis™ Fascial Closure System (1018S, 1018B, 1218S, 1218B, 1518S, 1518B)Suzhou Shenyun Medical Equipment Co., Ltd.2026—
+2K222944SafePath Sulturing System-Silk Suture, SafePath Sulturing System Polyamide…Safepath Medical, Inc.2024—
+1K241111AMT Suture PasserApplied Medical Technology, Inc.2024—
+1K133414Reprocessed Closure SystemSterilmed, Inc.20141

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199910
200610
201410
201810
202420
202610
FIG. 1 — Lineage of K980123, 1998–2026Source: 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 510(k) statement (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?

FDA’s file for it is a 510(k) statement, which names no predicate.

What descends from it? (7)

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

NumberDeviceApplicantDecidedDescendants
K180701SafePath Suturing SystemSafepath Medical, Inc.20181
K260197Shogun Axis™ Fascial Closure System (1018S, 1018B, 1218S, 1218B, 1518S, 1518B)Suzhou Shenyun Medical Equipment Co., Ltd.20260
K241111AMT Suture PasserApplied Medical Technology, Inc.20240
K133414Reprocessed Closure SystemSterilmed, Inc.20140
K053585Vanguard Reprocessed Suture PasserAscent Healthcare Solutions20060
K984600Metra PS Procedure KitInlet Medical, Inc.19990

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Aug 29, 2023Class IIZ-0985-2024Labeling Change ControlIncorrect component descriptions within the "Contents" section on the Tyvek lid for individual kit trays.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K180701 (Safepath Medical, Inc., 2018) 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—

What is it indicated for?

The Needle-Point Suture Passer is indicated to pass suture through soft tissues of the body during endoscopic/laparoscopic surgery.

Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.

More from Louisville Laboratories, Inc.

12 FDA decisions under this applicant name. See the company

  • K971796Laparotomy Bladder Neck Suspension Kit with Bone AnchorsLouisville Laboratories, Inc. · 1997
  • K971802Vaginal Suturing Kit for Bladder Neck SuspensionLouisville Laboratories, Inc. · 1997
  • K971791Vaginal Suturing Kit for Laparotomy Bladder Neck SuspensionLouisville Laboratories, Inc. · 1997
  • K971801Laparotomy Bladder Neck Suspension KitLouisville Laboratories, Inc. · 1997
  • K971797Laparoscopic Bladder Neck Suspension KitLouisville Laboratories, Inc. · 1997

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The GCJ category page

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https://510kreport.com/device/K980123 · printed Nov 4, 2026

Cite this page

510(k) Report. “K980123: Carter-Thomason Needle-Point Suture Passer Instrument Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K980123

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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