Cleared Traditional

K103726 - JARIT TAKE-APART ENDOSCOPIC INSTRUMENTS

K103726 is an FDA 510(k) clearance for JARIT TAKE-APART ENDOSCOPIC INSTRUMENTS, manufactured by Integra LifeSciences Corporation. The device is a Class 2 Obstetrics & Gynecology device with product code KNF cleared through the Traditional 510(k) pathway after a 413-day FDA review.

K103726 · Integra LifeSciences Corporation · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2012
Decision
413d
Days
Class 2
Risk

K103726 is an FDA 510(k) clearance for the JARIT TAKE-APART ENDOSCOPIC INSTRUMENTS. Classified as Coagulator-cutter, Endoscopic, Unipolar (and Accessories) (product code KNF), Class II - Special Controls.

Submitted by Integra LifeSciences Corporation (York, US). The FDA issued a Cleared decision on February 8, 2012 after a review of 413 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.4160 - the FDA obstetrics and gynecology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Obstetrics & Gynecology submissions.

View all Integra LifeSciences Corporation devices

FDA 510(k) Submission Details - K103726

510(k) Number K103726 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 22, 2010
Decision Date February 08, 2012
Days to Decision 413 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
253d slower than avg
Panel avg: 160d · This submission: 413d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KNF Device Classification - Class 2, Special Controls

Product Code KNF Coagulator-cutter, Endoscopic, Unipolar (and Accessories)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.4160
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Obstetrics & Gynecology devices follow this clearance model.

Regulatory Peers - KNF Coagulator-cutter, Endoscopic, Unipolar (and Accessories)

All 34
Devices cleared under the same product code (KNF) and FDA review panel - the closest regulatory comparables to K103726.
Sonata Sonography-Guided Transcervical Fibroid Ablation System
K173703 · Gynesonics, Inc. · Aug 2018
LINA GOLD LOOP HC
K132135 · Lina Medical Aps · Jan 2014
MODULAP LOOP
K121343 · Atc Technologies, Inc. · Jun 2013
LINA LOOP, MODELS: EL-160-4, EL-160-8, EL-200-4, EL-200-8
K070315 · Lina Medical Aps · Oct 2007
AESCULAP'S MODULAR ENDOSCOPIC INSTRUMENTS FOR GYNECOLOGY
K010752 · Aesculap, Inc. · Jun 2001
EPIDURAL CATHETER WITH CONNECTOR (AND ACCESSORY)
K010425 · Hdc Corp. · Mar 2001