SureClip

FDA 510(k) K150936 · Conmed Corporation

Substantially Equivalent

510(k) numberK150936

Submission

Device name
SureClip
Applicant
Conmed Corporation
Utica, NY, US
Received
April 7, 2015
Decision date
October 23, 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
FZP – Clip, Implantable
Device class
Class II (moderate risk)
Regulation
21 CFR 878.4300
Specialty
General, Plastic Surgery
Implant
Yes

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K230966angiOCCLUDE Ligating ClipsFZP · Traditional A2 Medical Systems, LLC09/19/2023SE
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Questions and answers

When was SureClip cleared by the FDA?

SureClip (K150936) received a 510(k) decision of Substantially Equivalent on October 23, 2015, 199 days after the submission was received.

What is the product code of K150936?

The FDA product code is FZP – Clip, Implantable, a Class II (moderate risk) device regulated under 21 CFR 878.4300.