Ackermann Europclip

FDA 510(k) K111930 · Ackermann Instrumente GmbH

Substantially Equivalent

510(k) numberK111930

Submission

Device name
Ackermann Europclip
Applicant
Ackermann Instrumente GmbH
Chesterland, OH, US
Received
July 7, 2011
Decision date
November 8, 2011
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 Ackermann Europclip cleared by the FDA?

Ackermann Europclip (K111930) received a 510(k) decision of Substantially Equivalent on November 8, 2011, 124 days after the submission was received.

What is the product code of K111930?

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