510(k) Report

510(k) · Cleared

Cleared

AdTec

K160393510(k) SpecialCleared May 26, 2016105-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 May 26, 2016 as substantially equivalent to K123102 (Aesculap, Inc., 2013) and 2 other predicates after a 105-day review. Its family tree reaches back 5 generations to 1994.

Decided
May 26, 2016
Review
105 days
Class
Class II
Product code
GCJ
Recalls
None
Predicates
3

Its longest line of descent runs back 5 generations to K945975 (1994). 26 ancestors in all, the oldest K912544 (1991). No later device cites it as a predicate yet.

Other ancestors, by year cleared 2013: 1 other ancestor1994: 3 other ancestors1999: 1 other ancestor1998: 1 other ancestor1996: 4 other ancestors1997: 4 other ancestors1995: 6 other ancestors1991: 1 other ancestorK945975 · Evershears (R) Scissors, Bilap (R) Probes, Bicoag (R) Forceps · Everest Medical Corp. · 1994K972558 · Bipolar Scissors · Enable Medical Corp. · 1997K981219 · Oscar Bipolar Scissors and Oscar Bipolar Reusable Cartridges · Enable Medical Corp. · 1998K992996 · Enable Endoscopic Bipolar Scissors · Enable Medical Corp. · 1999K001330 · Sovereign Bipolar Instruments · Aesculap, Inc. · 2000199019952000200520102015
Other ancestors, by generation 1 generation back: 2 other ancestors2 generations back: 3 other ancestors3 generations back: 13 other ancestors4 generations back: 3 other ancestors K001330 · Sovereign Bipolar Instruments · Aesculap, Inc. · 2000K992996 · Enable Endoscopic Bipolar Scissors · Enable Medical Corp. · 1999K981219 · Oscar Bipolar Scissors and Oscar Bipolar Reusable Cartridges · Enable Medical Corp. · 1998K972558 · Bipolar Scissors · Enable Medical Corp. · 1997K945975 · Evershears (R) Scissors, Bilap (R) Probes, Bicoag (R) Forceps · Everest Medical Corp. · 1994−50
  1. Root · 5 generations backK945975 Evershears (R) Scissors, Bilap (R) Probes, Bicoag (R) ForcepsEverest Medical Corp. · 1994
  2. 4 generations backK972558 Bipolar ScissorsEnable Medical Corp. · 1997
  3. 3 generations backK981219 Oscar Bipolar Scissors and Oscar Bipolar Reusable CartridgesEnable Medical Corp. · 1998
  4. 2 generations backK992996 Enable Endoscopic Bipolar ScissorsEnable Medical Corp. · 1999
  5. 1 generation backK001330 Sovereign Bipolar InstrumentsAesculap, Inc. · 2000
  6. This deviceK160393 AdTecAesculap, Inc. · 2016
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−5K945975Evershears (R) Scissors, Bilap (R) Probes, Bicoag (R) ForcepsEverest Medical Corp.1994—
−4K972558Bipolar ScissorsEnable Medical Corp.1997—
−3K981219Oscar Bipolar Scissors and Oscar Bipolar Reusable CartridgesEnable Medical Corp.1998—
−2K992996Enable Endoscopic Bipolar ScissorsEnable Medical Corp.1999—
−1K001330Sovereign Bipolar InstrumentsAesculap, Inc.2000—
0 (this device)K160393AdTecAesculap, Inc.2016—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199110
199430
199560
199640
199740
199810
199910
201310
FIG. 1 — Lineage of K160393, 1994–2016Source: 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
*K123102Sovereign Mini
Summary page 4
…SUBSTANTIAL EQUIVALENCE Aesculap®, Inc. believes the modified components of AdTec® are substantially equivalent to the components of the Aesculap Sovereign® mini System (K123102), Aesculap Endoscopic Instruments (K940936) and Aesculap Sovereign® Bipolar Instruments (K001330). DEVICE DESCRIPTION AdTec® is…
Aesculap, Inc.2013—
*K940936Aesculap Endoscopic Instruments
Summary page 4
…ieves the modified components of AdTec® are substantially equivalent to the components of the Aesculap Sovereign® mini System (K123102), Aesculap Endoscopic Instruments (K940936) and Aesculap Sovereign® Bipolar Instruments (K001330). DEVICE DESCRIPTION AdTec® is indicated for use in adult and pediatric di…
Aesculap, Inc.1994—
*K001330Sovereign Bipolar Instruments
Summary page 4
…lly equivalent to the components of the Aesculap Sovereign® mini System (K123102), Aesculap Endoscopic Instruments (K940936) and Aesculap Sovereign® Bipolar Instruments (K001330). DEVICE DESCRIPTION AdTec® is indicated for use in adult and pediatric diagnostic and therapeutic general endoscopy and laparos…
Aesculap, Inc.2000—

Also cleared against K123102: 2 other devices →

What descends from it?

No later submission names this one as a predicate yet.

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 22 years and passes through 3 companies; a new generation was cleared every 1.4 years on median.
  • None of the 26 ancestors has a recall.
  • 2 other devices also cite its predicate K123102.

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. 2016, 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?

Aesculap's AdTec® is indicated for use in adult and pediatric (3.5mm instruments only) diagnostic and therapeutic general endoscopy and laparoscopy surgery.

Indications for use as stated in the FDA summary.

Also cleared against K123102

2 other devices cite the same predicate.

  • K173919HX DeviceHuman Extension, Ltd. · 2018
  • K143299Percuvance (R) Percutaneous Surgical SystemTeleflexmedical, Inc. · 20152 recalls

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

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https://510kreport.com/device/K160393 · printed Nov 4, 2026

Cite this page

510(k) Report. “K160393: AdTec.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K160393

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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