510(k) Report

510(k) · Cleared

Cleared

Aesculap's Modular Endoscopic Instruments for Gynecology

K010752510(k) TraditionalCleared Jun 11, 200190-day reviewClass II21 CFR 884.4160

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

Aesculap, Inc. · KNF Coagulator-Cutter, Endoscopic, Unipolar (And Accessories)

Cleared on Jun 11, 2001 after a 90-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 later device descends from it.

Decided
Jun 11, 2001
Review
90 days
Class
Class II
Product code
KNF
Recalls
None
Predicates
0

1 later device descends from it, 1 citing it directly.

Descendants, by year cleared 2012: 1 descendant cleared200020052010201520202025
  1. This deviceK010752 Aesculap's Modular Endoscopic Instruments for GynecologyAesculap, Inc. · 2001
  2. Descendant · cites it directly · 0 of its ownK103726 Jarit Take-Apart Endoscopic InstrumentsIntegra LifeSciences Corporation · 2012 · Recalled

Most influential descendants

Showing 1 of 1 · See all
  • K103726Jarit Take-Apart Endoscopic InstrumentsIntegra LifeSciences Corporation · 2012 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K010752Aesculap's Modular Endoscopic Instruments for GynecologyAesculap, Inc.2001—
+1K103726Jarit Take-Apart Endoscopic InstrumentsIntegra LifeSciences Corporation20121

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201210
FIG. 1 — Lineage of K010752, 2001–2012Source: 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 KNF? 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 KNF device

  1. #1 K240503 Sonata Transcervical Fibroid Ablation System 2.2score 13.7 · 11 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 has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (1)

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

NumberDeviceApplicantDecidedDescendants
K103726Jarit Take-Apart Endoscopic InstrumentsIntegra LifeSciences Corporation20120

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?

  • Of its descendants, K103726 (Integra LifeSciences Corporation, 2012) has gone furthest, with 0 descendants of its own.

How does its category compare?

All KNF devices

KNF Coagulator-Cutter, Endoscopic, Unipolar (And Accessories): FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · KNF

1in 2025

2007: 12010: 12012: 12013: 12014: 12018: 12020: 12021: 12022: 12023: 12024: 12025: 12026 (partial year): 1
2007high 1 (2007) · low 0 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · KNF

Too few KNF 510(k)s in any year since 2007 to give a median.

Recalls per year · KNF

1in 2013

2009: 32013: 1
2007high 3 (2009) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · KNF

93in 2025

2008: 22009: 12010: 142011: 152012: 42013: 242014: 82015: 72016: 92017: 222018: 132019: 182020: 192021: 92022: 162023: 332024: 132025: 93
2007high 93 (2025) · low 0 (2007)2025

MAUDE reports naming product code KNF, 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
20071—00
20080—02
20090—31
20101—014
20110—015
20121—04
20131—124
20141—08
20150—07
20160—09
20170—022
20181—013
20190—018
20201—019
20211—09
20221—016
20231—033
20241—013
20251—093
20261—0—

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 KNF

The KNF category page

  • K254303Karl Storz SupraloopKarl Storz SE & CO. KG · 2026
  • K250705Sonata Transcervical Fibroid Ablation System 2.2Gynesonics, Inc. · 2025
  • K240503Sonata Transcervical Fibroid Ablation System 2.2Gynesonics, Inc. · 2024
  • K233848Sonata Transcervical Fibroid Ablation System 2.2 (SONATA2-220)Gynesonics, Inc. · 2023
  • K222304Sonata Transcervical Fibroid Ablation System 2.2Gynesonics, Inc. · 2022

https://510kreport.com/device/K010752 · printed Nov 6, 2026

Cite this page

510(k) Report. “K010752: Aesculap's Modular Endoscopic Instruments for Gynecology.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K010752

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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