Ticlip Sterial Disposable

FDA 510(k) K843589 · Western Medical Products, Inc.

Substantially Equivalent

510(k) numberK843589

Submission

Device name
Ticlip Sterial Disposable
Applicant
Western Medical Products, Inc.
Van Nuys, CA, US
Received
September 12, 1984
Decision date
October 24, 1984
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

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

Other 510(k)s with product code FZP

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K254231Inno-Hook™ Disposable Clip Appliers (Ligating Clips) and Inno-Hook™ Ligating ClipsFZP · Traditional Taiwan Surgical Corporation07/20/2026SE
K253903InnoClip Disposable Clip ApplierFZP · Special Taiwan Surgical Corporation12/22/2025SE
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

510(k)DeviceDecision
K891487Soft Lens Folding BlockHNR · Traditional 08/15/1989SE
K864266Ophthalmic Knife & ForcepsHNR · Traditional 11/28/1986SE

Questions and answers

When was Ticlip Sterial Disposable cleared by the FDA?

Ticlip Sterial Disposable (K843589) received a 510(k) decision of Substantially Equivalent on October 24, 1984, 42 days after the submission was received.

What is the product code of K843589?

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