510(k) Report

510(k) · Cleared

Recalled · Class II · 2018

Disposable Suture Placement System

K932553510(k) TraditionalCleared May 12, 1994351-day reviewClass II21 CFR 876.1500Recalls 2

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

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

Cleared on May 12, 1994 after a 351-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 8 later devices descend from it. It has been recalled 2 times.

Decided
May 12, 1994
Review
351 days
Class
Class II
Product code
GCJ
Recalls
2
Predicates
0

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

Descendants, by year cleared 1997: 3 descendants cleared1998: 1 descendant cleared2002: 3 descendants cleared2004: 1 descendant cleared1990200020102020
  1. This deviceK932553 Disposable Suture Placement SystemLaurus Medical Corp. · 1994
  2. Descendant · cites it directly · 5 of its ownK971797 Laparoscopic Bladder Neck Suspension KitLouisville Laboratories, Inc. · 1997
  3. Descendant · 2 generations on · 3 of its ownK011190 Surx Radiofrequency Electrosurgical Generator System and Accessories…Surx, Inc. · 2002
  4. Descendant · 3 generations on · 2 of its ownK020126 Modification to Surx Radiofrequency Electrosurgical Generator System…Surx, Inc. · 2002
  5. Descendant · 3 generations on · 1 of its ownK020952 Surx RF SystemSurx, Inc. · 2002
  6. Descendant · cites it directly · 1 of its ownK971791 Vaginal Suturing Kit for Laparotomy Bladder Neck SuspensionLouisville Laboratories, Inc. · 1997

Showing 5 of 8 descendants. See all descendants

Descendants cleared per year

1997: 31998: 12002: 32004: 1
1997high 3 (1997) · low 0 (1999)2026

Most influential descendants

Showing 5 of 8 · See all
  • K971797Laparoscopic Bladder Neck Suspension KitLouisville Laboratories, Inc. · 1997 · cites it directly5descendants
  • K011190Surx Radiofrequency Electrosurgical Generator System and Accessories (Surx LP System)Surx, Inc. · 2002 · 2 generations on3descendants
  • K020126Modification to Surx Radiofrequency Electrosurgical Generator System and Accessories…Surx, Inc. · 2002 · 3 generations on2descendants
  • K020952Surx RF SystemSurx, Inc. · 2002 · 3 generations on1descendant
  • K971791Vaginal Suturing Kit for Laparotomy Bladder Neck SuspensionLouisville Laboratories, Inc. · 1997 · cites it directly1descendant
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K932553Disposable Suture Placement SystemLaurus Medical Corp.1994—
+1K971797Laparoscopic Bladder Neck Suspension KitLouisville Laboratories, Inc.1997—
+2K011190Surx Radiofrequency Electrosurgical Generator System and Accessories (Surx LP…Surx, Inc.2002—
+3K020126Modification to Surx Radiofrequency Electrosurgical Generator System and…Surx, Inc.2002—
+3K020952Surx RF SystemSurx, Inc.2002—
+1K971791Vaginal Suturing Kit for Laparotomy Bladder Neck SuspensionLouisville Laboratories, Inc.1997—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199730
199810
200230
200410
FIG. 1 — Lineage of K932553, 1994–2004Source: 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
Get a 510(k) Report

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? (8)

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

NumberDeviceApplicantDecidedDescendants
K971797Laparoscopic Bladder Neck Suspension KitLouisville Laboratories, Inc.19975
K971791Vaginal Suturing Kit for Laparotomy Bladder Neck SuspensionLouisville Laboratories, Inc.19971
K971801Laparotomy Bladder Neck Suspension KitLouisville Laboratories, Inc.19971

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

Recalls of this device

DateClassRecallRoot causeReason
Feb 12, 2018Class IIZ-1620-2018Device DesignPotential for Capio sutures to break and /or detach.
Feb 12, 2018Class IIZ-1618-2018Device DesignPotential for Capio sutures to break and /or detach.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K971797 (Louisville Laboratories, Inc., 1997) has gone furthest, with 5 descendants 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—

More from Laurus Medical Corp.

4 FDA decisions under this applicant name. See the company

  • K973415Curvilinear Suture Placement SystemLaurus Medical Corp. · 1997
  • K973215Stereotactic Needle Core Biopsy SystemLaurus Medical Corp. · 1997
  • K960317Laurus Needle Core Biopsy SystemLaurus Medical Corp. · 1996

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https://510kreport.com/device/K932553 · printed Nov 6, 2026

Cite this page

510(k) Report. “K932553: Disposable Suture Placement System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K932553

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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