Lap Loop

FDA 510(k) K092897 · Medsys, S.A.

Substantially Equivalent

510(k) numberK092897

Submission

Device name
Lap Loop
Applicant
Medsys, S.A.
Claremont, NH, US
Received
September 21, 2009
Decision date
February 1, 2010
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
KNF – Coagulator-Cutter, Endoscopic, Unipolar (And Accessories)
Device class
Class II (moderate risk)
Regulation
21 CFR 884.4160
Specialty
Obstetrics/Gynecology

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K240503Sonata Transcervical Fibroid Ablation System 2.2KNF · Traditional Gynesonics, Inc.07/17/2024SE
K233848Sonata Transcervical Fibroid Ablation System 2.2 (SONATA2-220)KNF · Special Gynesonics, Inc.12/21/2023SE
K222304Sonata Transcervical Fibroid Ablation System 2.2KNF · Traditional Gynesonics, Inc.11/08/2022SE
K211535Sonata Transcervical Fibroid Ablation System 2.2KNF · Special Gynesonics, Inc.06/17/2021SE
K193516Sonata® Sonography-Guided Transcervical Fibroid Ablation System 2.1KNF · Traditional Gynesonics, Inc.05/04/2020SE
K173703Sonata Sonography-Guided Transcervical Fibroid Ablation SystemKNF · Traditional Gynesonics, Inc.08/15/2018SE
K132135Lina Gold Loop HCKNF · Traditional Lina Medical Aps01/31/2014SE
K121343Modulap LoopKNF · Traditional Atc Technologies, Inc.06/14/2013SE
K103726Jarit Take-Apart Endoscopic InstrumentsKNF · Traditional Integra LifeSciences Corporation02/08/2012SE

More from Integra LifeSciences Corporation

510(k)DeviceDecision
K062968Lapman Laparoscope Manipulator and Accessories, Model 900-200 SeriesGCJ · Special 01/03/2007SE
K023735Lapman Laparoscope Manipulator System and Accessories, Model 900-001GCJ · Abbreviated 08/07/2003SE

Questions and answers

When was Lap Loop cleared by the FDA?

Lap Loop (K092897) received a 510(k) decision of Substantially Equivalent on February 1, 2010, 133 days after the submission was received.

What is the product code of K092897?

The FDA product code is KNF – Coagulator-Cutter, Endoscopic, Unipolar (And Accessories), a Class II (moderate risk) device regulated under 21 CFR 884.4160.