510(k) Report

510(k) · Cleared

Recalled · Class II · 2024

Hybrid Trocar System

K101937510(k) SpecialCleared Aug 11, 201030-day reviewClass II21 CFR 876.1500Recalls 5

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

Aesculap, Inc. · GCJ Laparoscope, General & Plastic Surgery

Cleared on Aug 11, 2010 as substantially equivalent to K942053 (Aesculap, Inc., 1994) and 2 other predicates after a 30-day review. Its family tree reaches back 5 generations to 1993. 1 later device descends from it. It has been recalled 5 times.

Decided
Aug 11, 2010
Review
30 days
Class
Class II
Product code
GCJ
Recalls
5
Predicates
3

Its longest line of descent runs back 5 generations to K932648 (1993). 20 ancestors in all, the oldest K903206 (1990). 1 later device descends from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1998: 1 other ancestor1994: 3 other ancestors2006: 1 other ancestor2000: 1 other ancestor1997: 2 other ancestors1996: 1 other ancestor1995: 3 other ancestors2004: 1 other ancestor1991: 1 other ancestor1990: 1 other ancestor2015: 1 descendant clearedK932648 · Quick Switch Laparoscopic Instruments · Microline Pentax, Inc. · 1993K962119 · RE-New Laparoscopic Instruments · Microline Pentax, Inc. · 1996 · recalled×2: 2 generations cleared close together, K974066 (1998), K981389 (1998) K071976 · Vectec Disposable Trocars and Laparoscopic Accessories · Vectec · 20071990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 2 other ancestors2 generations back: 10 other ancestors3 generations back: 2 other ancestors4 generations back: 1 other ancestor 1 generation forward: 1 descendant K071976 · Vectec Disposable Trocars and Laparoscopic Accessories · Vectec · 2007K981389 · Disposable RE-New Forceps · Microline Pentax, Inc. · 1998 · recalledK974066 · RE-New Forceps Laparoscopic Surgical Tips · Microline Pentax, Inc. · 1998 · recalledK962119 · RE-New Laparoscopic Instruments · Microline Pentax, Inc. · 1996 · recalledK932648 · Quick Switch Laparoscopic Instruments · Microline Pentax, Inc. · 1993−50
  1. Root · 5 generations backK932648 Quick Switch Laparoscopic InstrumentsMicroline Pentax, Inc. · 1993
  2. 4 generations backK962119 RE-New Laparoscopic InstrumentsMicroline Pentax, Inc. · 1996 · Recalled
  3. 3 generations backK974066 RE-New Forceps Laparoscopic Surgical TipsMicroline Pentax, Inc. · 1998 · Recalled
  4. 2 generations backK981389 Disposable RE-New ForcepsMicroline Pentax, Inc. · 1998 · Recalled
  5. 1 generation backK071976 Vectec Disposable Trocars and Laparoscopic AccessoriesVectec · 2007
  6. This deviceK101937 Hybrid Trocar SystemAesculap, Inc. · 2010
  7. Descendant · cites it directly · 0 of its ownK153126 da Vinci Xi Hasson ConeIntuitive Surgical, Inc. · 2015

Most influential descendants

Showing 1 of 1 · See all
  • K153126da Vinci Xi Hasson ConeIntuitive Surgical, Inc. · 2015 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−5K932648Quick Switch Laparoscopic InstrumentsMicroline Pentax, Inc.1993—
−4K962119RE-New Laparoscopic InstrumentsMicroline Pentax, Inc.19962
−3K974066RE-New Forceps Laparoscopic Surgical TipsMicroline Pentax, Inc.19981
−2K981389Disposable RE-New ForcepsMicroline Pentax, Inc.19986
−1K071976Vectec Disposable Trocars and Laparoscopic AccessoriesVectec2007—
0 (this device)K101937Hybrid Trocar SystemAesculap, Inc.2010—
+1K153126da Vinci Xi Hasson ConeIntuitive Surgical, Inc.2015—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199010
199110
199430
199530
199610
199720
199810
200010
200410
200610

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201510
FIG. 1 — Lineage of K101937, 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), 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
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What was it cleared against? (3)

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
*K942053Aesculap Interchangeable Trocar Instrument Set
Summary page 1
…Inc. believes that the modified trocars and accessories are substantially equivalent to the existing components of the Aesculap Trocar Instrument Set (Interchangeable) (K942053) and Aesculap Needlescopic Instrument System (K982623) and VECTEC's Disposable Trocars (K071 976). DEVICE DESCRIPTION Aesculap's…
Aesculap, Inc.1994—
*K982623Aesculap Needlescopic Instrument System
Summary page 1
…es are substantially equivalent to the existing components of the Aesculap Trocar Instrument Set (Interchangeable) (K942053) and Aesculap Needlescopic Instrument System (K982623) and VECTEC's Disposable Trocars (K071 976). DEVICE DESCRIPTION Aesculap's Hybrid Trocar System can be used in laparoscopic gene…
Aesculap, Inc.1998—
*K071976Vectec Disposable Trocars and Laparoscopic Accessories
Summary page 1
…sting components of the Aesculap Trocar Instrument Set (Interchangeable) (K942053) and Aesculap Needlescopic Instrument System (K982623) and VECTEC's Disposable Trocars (K071 976). DEVICE DESCRIPTION Aesculap's Hybrid Trocar System can be used in laparoscopic general surgery, gynecology, and urology. The t…
Vectec2007—

Also cleared against K942053: 2 other devices →

What descends from it? (1)

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

NumberDeviceApplicantDecidedDescendants
K153126da Vinci Xi Hasson ConeIntuitive Surgical, Inc.20150

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

Recalls of this device

DateClassRecallRoot causeReason
Jan 9, 2024Class IIZ-1247-2024Packaging change controlThe sterile blister packaging may be damaged, and sterility may be compromised.
Jan 9, 2024Class IIZ-1246-2024Packaging change controlThe sterile blister packaging may be damaged, and sterility may be compromised.
Jan 9, 2024Class IIZ-1245-2024Packaging change controlThe sterile blister packaging may be damaged, and sterility may be compromised.
Jan 9, 2024Class IIZ-1243-2024Packaging change controlThe sterile blister packaging may be damaged, and sterility may be compromised.
Jan 9, 2024Class IIZ-1244-2024Packaging change controlThe sterile blister packaging may be damaged, and sterility may be compromised.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • The line of descent spans 17 years and passes through 3 companies; a new generation was cleared every 2.8 years on median.
  • 3 of the 20 ancestors have a recall of any class.
  • Of its descendants, K153126 (Intuitive Surgical, Inc., 2015) has gone furthest, with 0 descendants of its own.
  • 2 other devices also cite its predicate K942053.

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. 2010, this device’s year, is highlighted.

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 endoscopic instruments presented in this submission are for use in laparoscopy

(abdominal and gynecological surgery) for puncture of the abdominal cavity and

establishment of a port of entry for endoscopic instruments.

Indications for use as stated in the FDA summary.

Also cleared against K942053

2 other devices cite the same predicate.

  • K982623Aesculap Needlescopic Instrument SystemAesculap, Inc. · 1998
  • K981941Multaport Cannula Reducer and AccessoriesDexide, Inc. · 1998

More from Aesculap, Inc.

208 FDA decisions under this applicant name. See the company

  • K260044Ventricular Catheters, Thomale CatheterAesculap, Inc. · 2026
  • K242762Aesculap Aicon® Series Container SystemAesculap, Inc. · 2025
  • K242003XABO Ventricular Catheter, XABO Peritoneal Catheter, XABO Catheter SetAesculap, Inc. · 2024
  • K223596SQ.line KERRISONAesculap, Inc. · 2023
  • K214041Aesculap AICON ContainerAesculap, Inc. · 2022

Recent decisions in GCJ

The GCJ category page

  • K262455da Vinci 5 Handheld Camera Head (470080);da Vinci 5 Handheld Camera Laparoscope, 0 degree (470081);da Vinci…Intuitive Surgical, Inc. · 2026
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  • K260972OEV-271MUH LCD Monitor;OEV-321MUH LCD Monitor;OEV-431MUH LCD MonitorSony Corporation · 2026
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https://510kreport.com/device/K101937 · printed Nov 6, 2026

Cite this page

510(k) Report. “K101937: Hybrid Trocar System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K101937

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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