Diagnostic Sleeve, Reducer Sleeve

FDA 510(k) K941208 · New Eder Corp.

Substantially Equivalent

510(k) numberK941208

Submission

Device name
Diagnostic Sleeve, Reducer Sleeve
Applicant
New Eder Corp.
Elk Groove Village, IL, US
Received
March 14, 1994
Decision date
June 17, 1994
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.

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Questions and answers

When was Diagnostic Sleeve, Reducer Sleeve cleared by the FDA?

Diagnostic Sleeve, Reducer Sleeve (K941208) received a 510(k) decision of Substantially Equivalent on June 17, 1994, 95 days after the submission was received.

What is the product code of K941208?

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