510(k) Report

510(k) · Cleared

Recalled · Class II · 2012

Jarit Take-Apart Endoscopic Instruments

K103726510(k) TraditionalCleared Feb 8, 2012413-day reviewClass II21 CFR 884.4160Recalls 1

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

Integra LifeSciences Corporation · KNF Coagulator-Cutter, Endoscopic, Unipolar (And Accessories)

Cleared on Feb 8, 2012 as substantially equivalent to K932456 (J. Jamner Surgical Instruments, Inc., 1994) and 4 other predicates after a 413-day review. Its family tree reaches back 3 generations to 1994. It has been recalled once.

Decided
Feb 8, 2012
Review
413 days
Class
Class II
Product code
KNF
Recalls
1
Predicates
5

Its longest line of descent runs back 3 generations to K932832 (1994). 11 ancestors in all, the oldest K910831 (1991). No later device cites it as a predicate yet.

Other ancestors, by year cleared 2010: 1 other ancestor2001: 1 other ancestor1996: 1 other ancestor1994: 2 other ancestors1999: 1 other ancestor1993: 1 other ancestor1991: 1 other ancestorK932832 · Primus Insulated Forceps · Marlo Surgical Technology · 1994K021237 · Coopersurgical Laparoscopic Instruments · CooperSurgical, Inc. · 2003K043013 · Miltex Laparoscopic Instruments · Miltex, Inc. · 200519901995200020052010
Other ancestors, by generation 1 generation back: 4 other ancestors2 generations back: 2 other ancestors3 generations back: 2 other ancestors K043013 · Miltex Laparoscopic Instruments · Miltex, Inc. · 2005K021237 · Coopersurgical Laparoscopic Instruments · CooperSurgical, Inc. · 2003K932832 · Primus Insulated Forceps · Marlo Surgical Technology · 19940
  1. Root · 3 generations backK932832 Primus Insulated ForcepsMarlo Surgical Technology · 1994
  2. 2 generations backK021237 Coopersurgical Laparoscopic InstrumentsCooperSurgical, Inc. · 2003
  3. 1 generation backK043013 Miltex Laparoscopic InstrumentsMiltex, Inc. · 2005
  4. This deviceK103726 Jarit Take-Apart Endoscopic InstrumentsIntegra LifeSciences Corporation · 2012
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K932832Primus Insulated ForcepsMarlo Surgical Technology1994—
−2K021237Coopersurgical Laparoscopic InstrumentsCooperSurgical, Inc.2003—
−1K043013Miltex Laparoscopic InstrumentsMiltex, Inc.2005—
0 (this device)K103726Jarit Take-Apart Endoscopic InstrumentsIntegra LifeSciences Corporation2012—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199110
199310
199420
199610
199910
200110
201010
FIG. 1 — Lineage of K103726, 1994–2012Source: 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), 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 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? (5)

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
*K932456Jarit Surgical Instruments
Summary page 2
…nA.Integralifecom Predicate Devices: 510(k) # Device Manufacturer Product Code K932456 Jarit Surgical Instruments Integra York PA, Inc. KNF K010752 Aesculap Modular Endo. Instr. Aesculap, Inc.…
J. Jamner Surgical Instruments, Inc.19941
*K010752Aesculap's Modular Endoscopic Instruments for Gynecology
Summary page 2
…Predicate Devices: 510(k) # Device Manufacturer Product Code K932456 Jarit Surgical Instruments Integra York PA, Inc. KNF K010752 Aesculap Modular Endo. Instr. Aesculap, Inc. KNF K 103282 Laparoscopic Dissector Applied Medical Resources…
Aesculap, Inc.2001—
*K103282Laparoscopic Dissector
Summary page 2
…Product Code K932456 Jarit Surgical Instruments Integra York PA, Inc. KNF K010752 Aesculap Modular Endo. Instr. Aesculap, Inc. KNF K 103282 Laparoscopic Dissector Applied Medical Resources GEl K962 119 Re-New Laparoscopic Instir, Microline Surgical, Inc.…
Applied Medical Resources Corp.2010—
*K962119RE-New Laparoscopic Instruments
Summary page 2
…York PA, Inc. KNF K010752 Aesculap Modular Endo. Instr. Aesculap, Inc. KNF K 103282 Laparoscopic Dissector Applied Medical Resources GEl K962 119 Re-New Laparoscopic Instir, Microline Surgical, Inc. GET K043013 Miltex Laparoscopic Instir. Miltex, Inc.…
Microline Pentax, Inc.19962
*K043013Miltex Laparoscopic Instruments
Summary page 2
…, Inc. KNF K 103282 Laparoscopic Dissector Applied Medical Resources GEl K962 119 Re-New Laparoscopic Instir, Microline Surgical, Inc. GET K043013 Miltex Laparoscopic Instir. Miltex, Inc. HET Performance Standards: No performance standards have been promu…
Miltex, Inc.2005—

Also cleared against K932456: 1 other device →

What descends from it?

No later submission names this one as a predicate yet.

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

Recalls of this device

DateClassRecallRoot causeReason
May 23, 2012Class IIZ-2028-2012Nonconforming Material/ComponentThe Integra(TM) Jarit(R) Take-Apart Laparoscopic Instrument shafts were released with internal component out of specification.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • The line of descent spans 18 years and passes through 4 companies; a new generation was cleared every 6.9 years on median.
  • 3 of the 11 ancestors have a recall of any class.
  • 1 other device also cites its predicate K932456.

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. 2012, this device’s year, is highlighted.

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—

What is it indicated for?

Integra TM Jarit® Take-Apart Endoscopic Instruments are intended for use in

laparoscopic gynecologic surgery and other operative procedures under endoscopic

observations. For use when a rigid endoscopic instrument for grasping, dissecting

and/or other manipulation of soft tissue is determined to be appropriate by the surgeon.

For those instruments with electrosurgical capability, current can be used for

coagulation and/or culling as determined necessary and appropriate by the surgeon.

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 K932456

1 other device cites the same predicate.

  • K120012Integra Jarit Video Assisted Thoracic Surgery InstrumentsIntegra LifeSciences Corporation · 2012

More from Integra LifeSciences Corporation

355 FDA decisions under this applicant name. See the company

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  • P810006/S114Collastat™ Absorbable Collagen Hemostatic Sponge and Collastat™ Absorbable Collagen Hemostatic Agent -…Integra LifeSciences Corporation · 2026
  • P850010/S118Helistat® Absorbable Collagen Hemostatic Agent and Helitene® Absorbable Collagen Hemostatic Agent -…Integra LifeSciences Corporation · 2026
  • P810006/S113Collastat™ Absorbable Collagen Hemostatic SpongeIntegra LifeSciences Corporation · 2026

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/K103726 · printed Nov 6, 2026

Cite this page

510(k) Report. “K103726: Jarit Take-Apart Endoscopic Instruments.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K103726

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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