Duoclipper Titanium Clips

FDA 510(k) K973652 · Scion International, Inc.

Substantially Equivalent

510(k) numberK973652

Submission

Device name
Duoclipper Titanium Clips
Applicant
Scion International, Inc.
Miami, FL, US
Received
September 25, 1997
Decision date
March 27, 1998
Decision
Substantially Equivalent (SESE)
Type
Traditional 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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K253781InnoClip Clip ApplierFZP · Special Taiwan Surgical Corporation12/22/2025SE
K250643Disposable Polymer Ligation ClipsFZP · Traditional Hangzhou Kangji Medical Instrument Co., Ltd.11/20/2025SE
K251054Hem-o-lok™ PurplePlus™ Large Polymer Ligating ClipsFZP · Traditional Teleflex Medical07/03/2025SE
K242541Gem ZipclipFZP · Traditional Synovis Micro Companies Alliance A Subsidiary of…01/15/2025SE
K221495SOLID CLIP™ Single Use Clip ApplierFZP · Traditional Medscope Biotech Co., Ltd.07/18/2024SE
K232970Hem-o-lok® Ligating ClipsFZP · Traditional Teleflex Medical01/12/2024SE
K230966angiOCCLUDE Ligating ClipsFZP · Traditional A2 Medical Systems, LLC09/19/2023SE
K232313LIGACLIP Endoscopic Rotating Multiple Clip Applier 12mm L (ER420); LIGACLIP Endoscopic…FZP · Special Ethicon Endo Surgery, LLC08/29/2023SE

More from Ethicon Endo Surgery, LLC

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K973698Scion Balloon ElevatorGCJ · Traditional 03/31/1998SE
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Questions and answers

When was Duoclipper Titanium Clips cleared by the FDA?

Duoclipper Titanium Clips (K973652) received a 510(k) decision of Substantially Equivalent on March 27, 1998, 183 days after the submission was received.

What is the product code of K973652?

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