GMD Universal Circumcision Clamp, Model 200

FDA 510(k) K063429 · Generic Medical Device, Inc.

Substantially Equivalent

510(k) numberK063429

Submission

Device name
GMD Universal Circumcision Clamp, Model 200
Applicant
Generic Medical Device, Inc.
Houston, TX, US
Received
November 13, 2006
Decision date
January 17, 2007
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
HFX – Clamp, Circumcision
Device class
Class II (moderate risk)
Regulation
21 CFR 884.4530
Specialty
Obstetrics/Gynecology

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Questions and answers

When was GMD Universal Circumcision Clamp, Model 200 cleared by the FDA?

GMD Universal Circumcision Clamp, Model 200 (K063429) received a 510(k) decision of Substantially Equivalent on January 17, 2007, 65 days after the submission was received.

What is the product code of K063429?

The FDA product code is HFX – Clamp, Circumcision, a Class II (moderate risk) device regulated under 21 CFR 884.4530.