Cit Two Way Suctin and Irrigation Tubes

FDA 510(k) K944268 · Chirurgische Instrumente

Substantially Equivalent

510(k) numberK944268

Submission

Device name
Cit Two Way Suctin and Irrigation Tubes
Applicant
Chirurgische Instrumente
Balgheim, DE
Received
September 1, 1994
Decision date
January 26, 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
K944444Cit Biopsy PunchesHFB · Traditional 09/29/1995SE
K944270Cit Monopolar Laparoscopic InstrmentsHET · Traditional 07/25/1995SE
K944269Cit Grasping and Dissecting ForcepsHET · Traditional 01/24/1995SE

Questions and answers

When was Cit Two Way Suctin and Irrigation Tubes cleared by the FDA?

Cit Two Way Suctin and Irrigation Tubes (K944268) received a 510(k) decision of Substantially Equivalent on January 26, 1995, 147 days after the submission was received.

What is the product code of K944268?

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