Circumplast Circumcision Device

FDA 510(k) K151095 · Novadien Healthcare

Substantially Equivalent

510(k) numberK151095

Submission

Device name
Circumplast Circumcision Device
Applicant
Novadien Healthcare
Mount Lewis, AU
Received
April 23, 2015
Decision date
September 18, 2015
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

Other 510(k)s with product code HFX

510(k)DeviceApplicantDecision
K251687Konig Bell Circumcision ClampHFX · Traditional Medline Industries, LP02/25/2026SE
K221356Wee BellHFX · Traditional Wee Medical02/02/2023SE
K212911Konig Mogen ClampHFX · Traditional Medline Industries, Inc.11/18/2022SE
K142163Male Circumcision Kits:RapideclampHFX · Traditional Medicfit Technology Sdn Bhd04/20/2015SE
K131373ShangringHFX · Special Wuhu Snnda Medical Treatment Appliance Technology06/25/2013SE
K121789ShangringHFX · Traditional Wuhu Snna Medical Treatment Appliance Technology C08/03/2012SE
K103695Prepex SystemHFX · Traditional Circ Medtech01/10/2012SE
K100916Medicon Mogen ClampHFX · Traditional Medicon EG12/06/2010SE
K061539Gomco Circumcision Clamp, Mogen Clamp, Plastibell Circumcision DeviceHFX · Traditional Clinical Innovations, LLC09/20/2007SE
K063429GMD Universal Circumcision Clamp, Model 200HFX · Traditional Generic Medical Device, Inc.01/17/2007SE

Questions and answers

When was Circumplast Circumcision Device cleared by the FDA?

Circumplast Circumcision Device (K151095) received a 510(k) decision of Substantially Equivalent on September 18, 2015, 148 days after the submission was received.

What is the product code of K151095?

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