Dual Valve Aspiration/Lavage Cannula and Aspiration/Suction Probe

FDA 510(k) K941206 · New Eder Corp.

Substantially Equivalent

510(k) numberK941206

Submission

Device name
Dual Valve Aspiration/Lavage Cannula and Aspiration/Suction Probe
Applicant
New Eder Corp.
Elk Groove Village, IL, US
Received
March 14, 1994
Decision date
July 25, 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
HET – Laparoscope, Gynecologic (And Accessories)
Device class
Class II (moderate risk)
Regulation
21 CFR 884.1720
Specialty
Obstetrics/Gynecology

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More from 270surgical , Ltd.

510(k)DeviceDecision
K941435Bipolar U-Shape Handle, Prongs, and CordGEI · Traditional 04/11/1995SE
K941207Monopolar Suction Cannula; Monopolar ElectrodesKNF · Traditional 01/24/1995SE
K941208Diagnostic Sleeve, Reducer SleeveHET · Traditional 06/17/1994SE

Questions and answers

When was Dual Valve Aspiration/Lavage Cannula and Aspiration/Suction Probe cleared by the FDA?

Dual Valve Aspiration/Lavage Cannula and Aspiration/Suction Probe (K941206) received a 510(k) decision of Substantially Equivalent on July 25, 1995, 498 days after the submission was received.

What is the product code of K941206?

The FDA product code is HET – Laparoscope, Gynecologic (And Accessories), a Class II (moderate risk) device regulated under 21 CFR 884.1720.