Monopolar Suction Cannula; Monopolar Electrodes

Q: What is the product code of K941207?

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

FDA 510(k) K941207 · New Eder Corp.

Substantially Equivalent

510(k) numberK941207

Submission

Device name: Monopolar Suction Cannula; Monopolar Electrodes
Applicant: New Eder Corp.
Elk Groove Village, IL, US
Received: March 14, 1994
Decision date: January 24, 1995
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) statement 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

Other 510(k)s with product code KNF

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K250705	Sonata Transcervical Fibroid Ablation System 2.2KNF · Special	Gynesonics, Inc.	04/02/2025SE
K240503	Sonata Transcervical Fibroid Ablation System 2.2KNF · Traditional	Gynesonics, Inc.	07/17/2024SE
K233848	Sonata Transcervical Fibroid Ablation System 2.2 (SONATA2-220)KNF · Special	Gynesonics, Inc.	12/21/2023SE
K222304	Sonata Transcervical Fibroid Ablation System 2.2KNF · Traditional	Gynesonics, Inc.	11/08/2022SE
K211535	Sonata Transcervical Fibroid Ablation System 2.2KNF · Special	Gynesonics, Inc.	06/17/2021SE
K193516	Sonata® Sonography-Guided Transcervical Fibroid Ablation System 2.1KNF · Traditional	Gynesonics, Inc.	05/04/2020SE
K173703	Sonata Sonography-Guided Transcervical Fibroid Ablation SystemKNF · Traditional	Gynesonics, Inc.	08/15/2018SE
K132135	Lina Gold Loop HCKNF · Traditional	Lina Medical Aps	01/31/2014SE
K121343	Modulap LoopKNF · Traditional	Atc Technologies, Inc.	06/14/2013SE
K103726	Jarit Take-Apart Endoscopic InstrumentsKNF · Traditional	Integra LifeSciences Corporation	02/08/2012SE

More from Integra LifeSciences Corporation

510(k)	Device	Decision
K941206	Dual Valve Aspiration/Lavage Cannula and Aspiration/Suction ProbeHET · Traditional	07/25/1995SE
K941435	Bipolar U-Shape Handle, Prongs, and CordGEI · Traditional	04/11/1995SE
K941208	Diagnostic Sleeve, Reducer SleeveHET · Traditional	06/17/1994SE

Questions and answers

When was Monopolar Suction Cannula; Monopolar Electrodes cleared by the FDA?

Monopolar Suction Cannula; Monopolar Electrodes (K941207) received a 510(k) decision of Substantially Equivalent on January 24, 1995, 316 days after the submission was received.

What is the product code of K941207?

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