Ivs Clip Closure System, Model 1002 (Ivs Clip Applier); Ivs Intruducer Set, Model 1001

Q: What is the product code of K020879?

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

FDA 510(k) K020879 · Integrated Vascular Systems, Inc.

Substantially Equivalent

510(k) numberK020879

Submission

Device name: Ivs Clip Closure System, Model 1002 (Ivs Clip Applier); Ivs Intruducer Set, Model 1001
Applicant: Integrated Vascular Systems, Inc.
Sunnyvale, CA, US
Received: March 18, 2002
Decision date: September 25, 2002
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

Other 510(k)s with product code FZP

510(k)	Device	Applicant	Decision
K254231	Inno-Hook Disposable Clip Appliers (Ligating Clips) and Inno-Hook Ligating ClipsFZP · Traditional	Taiwan Surgical Corporation	07/20/2026SE
K253903	InnoClip Disposable Clip ApplierFZP · Special	Taiwan Surgical Corporation	12/22/2025SE
K253781	InnoClip Clip ApplierFZP · Special	Taiwan Surgical Corporation	12/22/2025SE
K250643	Disposable Polymer Ligation ClipsFZP · Traditional	Hangzhou Kangji Medical Instrument Co., Ltd.	11/20/2025SE
K251054	Hem-o-lok PurplePlus Large Polymer Ligating ClipsFZP · Traditional	Teleflex Medical	07/03/2025SE
K242541	Gem ZipclipFZP · Traditional	Synovis Micro Companies Alliance A Subsidiary of…	01/15/2025SE
K221495	SOLID CLIP Single Use Clip ApplierFZP · Traditional	Medscope Biotech Co., Ltd.	07/18/2024SE
K232970	Hem-o-lok® Ligating ClipsFZP · Traditional	Teleflex Medical	01/12/2024SE
K230966	angiOCCLUDE Ligating ClipsFZP · Traditional	A2 Medical Systems, LLC	09/19/2023SE
K232313	LIGACLIP Endoscopic Rotating Multiple Clip Applier 12mm L (ER420); LIGACLIP Endoscopic…FZP · Special	Ethicon Endo Surgery, LLC	08/29/2023SE

More from Ethicon Endo Surgery, LLC

510(k)	Device	Decision
K031583	Modification to Ivs Introducer Set, Model 1003DYB · Special	06/16/2003SE
K030723	Ivs Introducer Set, Model 1003DYB · Traditional	04/03/2003SE

Questions and answers

When was Ivs Clip Closure System, Model 1002 (Ivs Clip Applier); Ivs Intruducer Set, Model 1001 cleared by the FDA?

Ivs Clip Closure System, Model 1002 (Ivs Clip Applier); Ivs Intruducer Set, Model 1001 (K020879) received a 510(k) decision of Substantially Equivalent on September 25, 2002, 191 days after the submission was received.

What is the product code of K020879?

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