510(k) Report

510(k) · Cleared

Cleared

Aesculap Needlescopic Instrument System

K982623510(k) TraditionalCleared Sep 30, 199864-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

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

Cleared on Sep 30, 1998 as substantially equivalent to K942053 (Aesculap, Inc., 1994) and 8 other predicates after a 64-day review. Its family tree reaches back 2 generations to 1991. 17 later devices descend from it.

Decided
Sep 30, 1998
Review
64 days
Class
Class II
Product code
GCJ
Recalls
None
Predicates
9

Its longest line of descent runs back 2 generations to K912544 (1991). 10 ancestors in all. 17 later devices descend from it, 3 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1997: 1 other ancestor1996: 1 other ancestor1995: 3 other ancestors1994: 3 other ancestors2013: 2 descendants cleared2010: 1 descendant cleared2015: 2 descendants cleared2016: 2 descendants cleared2018: 2 descendants cleared2021: 2 descendants cleared2025: 2 descendants cleared2023: 3 descendants cleared2026: 1 descendant clearedK912544 · Bipolar Forceps · Everest Medical Corp. · 1991K972415 · Minisite*Bipolar Forceps** Device · United States Surgical, A Division of Tyco Healthc · 19971990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 8 other ancestors 1 generation forward: 3 descendants2 generations forward: 4 descendants3 generations forward: 7 descendants4 generations forward: 3 descendants K972415 · Minisite*Bipolar Forceps** Device · United States Surgical, A Division of Tyco Healthc · 1997K912544 · Bipolar Forceps · Everest Medical Corp. · 19910
  1. Root · 2 generations backK912544 Bipolar ForcepsEverest Medical Corp. · 1991
  2. 1 generation backK972415 Minisite*Bipolar Forceps** DeviceUnited States Surgical, A Division of Tyco Healthc · 1997
  3. This deviceK982623 Aesculap Needlescopic Instrument SystemAesculap, Inc. · 1998
  4. Descendant · cites it directly · 13 of its ownK123102 Sovereign MiniAesculap, Inc. · 2013
  5. Descendant · 2 generations on · 8 of its ownK173919 HX DeviceHuman Extension, Ltd. · 2018
  6. Descendant · 3 generations on · 3 of its ownK203603 Monopolar HookHuman Xtensions, Ltd. · 2021
  7. Descendant · 2 generations on · 2 of its ownK143299 Percuvance (R) Percutaneous Surgical SystemTeleflexmedical, Inc. · 2015 · Recalled
  8. Descendant · 3 generations on · 1 of its ownK153063 Percuvance Percutaneous Surgical SystemTeleflexmedical, Inc. · 2016 · Recalled

Showing 5 of 17 descendants. See all descendants

Descendants cleared per year

2010: 12013: 22015: 22016: 22018: 22021: 22023: 32025: 22026: 1
2010high 3 (2023) · low 0 (2011)2026

Most influential descendants

Showing 5 of 17 · See all
  • K123102Sovereign MiniAesculap, Inc. · 2013 · cites it directly13descendants
  • K173919HX DeviceHuman Extension, Ltd. · 2018 · 2 generations on8descendants
  • K203603Monopolar HookHuman Xtensions, Ltd. · 2021 · 3 generations on3descendants
  • K143299Percuvance (R) Percutaneous Surgical SystemTeleflexmedical, Inc. · 2015 · 2 generations on2descendants
  • K153063Percuvance Percutaneous Surgical SystemTeleflexmedical, Inc. · 2016 · 3 generations on1descendant
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K912544Bipolar ForcepsEverest Medical Corp.1991—
−1K972415Minisite*Bipolar Forceps** DeviceUnited States Surgical, A Division of Tyco Healthc1997—
0 (this device)K982623Aesculap Needlescopic Instrument SystemAesculap, Inc.1998—
+1K123102Sovereign MiniAesculap, Inc.2013—
+2K173919HX DeviceHuman Extension, Ltd.2018—
+3K203603Monopolar HookHuman Xtensions, Ltd.2021—
+2K143299Percuvance (R) Percutaneous Surgical SystemTeleflexmedical, Inc.20152
+3K153063Percuvance Percutaneous Surgical SystemTeleflexmedical, Inc.20169

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199430
199530
199610
199710

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201010
201320
201520
201620
201820
202120
202330
202520
202610
FIG. 1 — Lineage of K982623, 1991–2026Source: 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 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? (10)

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 2
…sion is substantially equivalent in design, function, and intended use to currently marketed endoscopic systems, such as: » Aesculap Endoscopy Instruments by Aesculap (#K942053, #K941239, #K942730, #K940936)) e MicroLap System by Imagyn Medical Inc. (#K965055) « Miniature Laparoscope Set (Mini Lap) by Ric…
Aesculap, Inc.1994—
*K941239Aesculap Neuroendoscope
Summary page 2
…bstantially equivalent in design, function, and intended use to currently marketed endoscopic systems, such as: » Aesculap Endoscopy Instruments by Aesculap (#K942053, #K941239, #K942730, #K940936)) e MicroLap System by Imagyn Medical Inc. (#K965055) « Miniature Laparoscope Set (Mini Lap) by Richard Wolf…
Aesculap, Inc.1994—
*K942730Aesculap Laparoscopes
Summary page 2
…y equivalent in design, function, and intended use to currently marketed endoscopic systems, such as: » Aesculap Endoscopy Instruments by Aesculap (#K942053, #K941239, #K942730, #K940936)) e MicroLap System by Imagyn Medical Inc. (#K965055) « Miniature Laparoscope Set (Mini Lap) by Richard Wolf GMBH (#K96…
Aesculap, Inc.1995—
*K940936Aesculap Endoscopic Instruments
Summary page 2
…nt in design, function, and intended use to currently marketed endoscopic systems, such as: » Aesculap Endoscopy Instruments by Aesculap (#K942053, #K941239, #K942730, #K940936)) e MicroLap System by Imagyn Medical Inc. (#K965055) « Miniature Laparoscope Set (Mini Lap) by Richard Wolf GMBH (#K962799) o KO…
Aesculap, Inc.1994—
*K965055Imagyn Microlap and Micro Lap-Gold Laparoscopes
Summary page 2
…marketed endoscopic systems, such as: » Aesculap Endoscopy Instruments by Aesculap (#K942053, #K941239, #K942730, #K940936)) e MicroLap System by Imagyn Medical Inc. (#K965055) « Miniature Laparoscope Set (Mini Lap) by Richard Wolf GMBH (#K962799) o KOH Micro-Suturing Instruments by Karl Storz Endoscopy-…
Imagyn Medical, Inc.1997—
*K962799Miniature Laparoscope Set (Mini Lap)
Summary page 2
…s by Aesculap (#K942053, #K941239, #K942730, #K940936)) e MicroLap System by Imagyn Medical Inc. (#K965055) « Miniature Laparoscope Set (Mini Lap) by Richard Wolf GMBH (#K962799) o KOH Micro-Suturing Instruments by Karl Storz Endoscopy-America, Inc. (#K955479) « Semi-Rigid Micro Endoscopes and Accessories…
Richard Wolf GmbH1996—
*K955479Koh Micro-Suturing Instruments
Summary page 2
…n Medical Inc. (#K965055) « Miniature Laparoscope Set (Mini Lap) by Richard Wolf GMBH (#K962799) o KOH Micro-Suturing Instruments by Karl Storz Endoscopy-America, Inc. (#K955479) « Semi-Rigid Micro Endoscopes and Accessories for Adult and Pediatric General Endoscopic and Laparoscopic Surgery by Karl Storz…
KARL STORZ Endoscopy-America, Inc.1995—
*K946164KS Semi-Rigid Micro-Endoscopes and Accessories for Adult and Pediatric General…
Summary page 2
…Inc. (#K955479) « Semi-Rigid Micro Endoscopes and Accessories for Adult and Pediatric General Endoscopic and Laparoscopic Surgery by Karl Storz Endoscopy-America, Inc. (#K946164) » Minisite 2mm Microlaparoscopy System by United States Surgical Corporation (#K972415) « Micro-L Laparoscopy System by Circon C…
KARL STORZ Endoscopy-America, Inc.1995—
*K972415Minisite*Bipolar Forceps** Device
Summary page 2
…neral Endoscopic and Laparoscopic Surgery by Karl Storz Endoscopy-America, Inc. (#K946164) » Minisite 2mm Microlaparoscopy System by United States Surgical Corporation (#K972415) « Micro-L Laparoscopy System by Circon Corporation (#K unknown) LRVIC IS ‘/é DEPARTMENT OF HEALTH & HUMAN SERVI…
United States Surgical, A Division of Tyco Healthc1997—
*—Micro-L Laparoscopy System
Named without a submission number
—

Also cleared against K942053: 2 other devices →

What descends from it? (17)

See all 17

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

NumberDeviceApplicantDecidedDescendants
K123102Sovereign MiniAesculap, Inc.201313
K101937Hybrid Trocar SystemAesculap, Inc.20101
K132232Mins Needlescopic Resposable Device SystemMinilap Technologies20130

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?

  • The line of descent spans 7 years and passes through 3 companies; a new generation was cleared every 6.2 years on median.
  • None of the 10 ancestors has a recall.
  • Of its descendants, K123102 (Aesculap, Inc., 2013) has gone furthest, with 13 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.

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?

Aesculap's Needlescopic Instrument System (N.I.S.) is indicated for use in adult and pediatric diagnostic and therapeutic general endoscopy and laparoscopy surgery.

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 K942053

2 other devices cite the same predicate.

  • K101937Hybrid Trocar SystemAesculap, Inc. · 20105 recalls
  • 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
  • K262397CuratOR EX2742Eizo Corporation · 2026
  • K260884UNIDRIVE Select SystemKarl Storz SE & CO. KG · 2026
  • K260972OEV-271MUH LCD Monitor;OEV-321MUH LCD Monitor;OEV-431MUH LCD MonitorSony Corporation · 2026
  • K261139VereSee (VER150, VER200, VER151, VER201, VER200C, and VER-100-103)Freyja Healthcare, LLC · 2026

https://510kreport.com/device/K982623 · printed Nov 4, 2026

Cite this page

510(k) Report. “K982623: Aesculap Needlescopic Instrument System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K982623

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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