Modulap Loop

FDA 510(k) K121343 · Atc Technologies, Inc.

Substantially Equivalent

510(k) numberK121343

Submission

Device name
Modulap Loop
Applicant
Atc Technologies, Inc.
Dover, MA, US
Received
May 4, 2012
Decision date
June 14, 2013
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
K103726Jarit Take-Apart Endoscopic InstrumentsKNF · Traditional Integra LifeSciences Corporation02/08/2012SE
K092897Lap LoopKNF · Traditional Medsys, S.A.02/01/2010SE

More from Medsys, S.A.

510(k)DeviceDecision
K010473Sparrowhawk DisposableDWZ · Traditional 06/06/2001SE
K994319ModulapGEI · Traditional 03/20/2000SE
K983623ModulapGCJ · Traditional 12/18/1998SE

Questions and answers

When was Modulap Loop cleared by the FDA?

Modulap Loop (K121343) received a 510(k) decision of Substantially Equivalent on June 14, 2013, 406 days after the submission was received.

What is the product code of K121343?

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