Amsel Occluder Device

FDA 510(k) K172479 · Amsel Medical

Substantially Equivalent

510(k) numberK172479

Submission

Device name
Amsel Occluder Device
Applicant
Amsel Medical
Cambridge, MA, US
Received
August 16, 2017
Decision date
September 14, 2017
Decision
Substantially Equivalent (SESE)
Type
Special 510(k)
Summary
510(k) statement 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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More from Ethicon Endo Surgery, LLC

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K180650Amsel Endo OccluderFZP · Traditional 11/15/2018SE
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Questions and answers

When was Amsel Occluder Device cleared by the FDA?

Amsel Occluder Device (K172479) received a 510(k) decision of Substantially Equivalent on September 14, 2017, 29 days after the submission was received.

What is the product code of K172479?

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