Surgical Spring Clips

FDA 510(k) K883909 · Applied Vascular Devices, Inc.

Substantially Equivalent

510(k) numberK883909

Submission

Device name
Surgical Spring Clips
Applicant
Applied Vascular Devices, Inc.
Santa Ana, CA, US
Received
September 15, 1988
Decision date
December 27, 1988
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
DSS – Clip, Vascular
Device class
Class II (moderate risk)
Regulation
21 CFR 870.3250
Specialty
Cardiovascular
Implant
Yes

Other 510(k)s with product code DSS

510(k)DeviceApplicantDecision
K983744Mcas (Modular Clip Applier System)DSS · Traditional Applied Medical Resources01/21/1999SE
K961333Heartport Multifire Clip ApplierDSS · Traditional Heartport, Inc.11/15/1996SE
K920104Identi Loops Degania SiliconeDSS · Traditional Puritas Health Care, Inc.04/20/1992SE
K920676Rmi SofclampDSS · Traditional Research Medical, Inc.04/15/1992SE
K914523Cri Vessel Occlusin System/Cri Occlusion CoilDSS · Traditional Catheter Research C/O Burditt, Bowles & Radzius01/10/1992SE
K901303Horizon Surgical Ligating and Marking ClipDSS · Traditional Horizon Surgical, Inc.06/05/1990SE
K771021Auto-ClipDSS · Traditional Axiom Medical, Inc.06/14/1977SE

More from Axiom Medical, Inc.

510(k)DeviceDecision
K911730Surgical Obturator with SealGCJ · Traditional 12/23/1991SE
K911589Disposable Surgical Trocar with SealGCJ · Traditional 07/05/1991SE
K910339Avd Intimax Occlusion CatheterDQT · Traditional 05/29/1991SE
K910372Intimax Thrombectomy CatheterDXE · Traditional 04/26/1991SE
K911181Intimax(Tm) Irrigation CatheterGCA · Traditional 04/18/1991SE
K910493Avd Intimax Cholangiography CatheterFGE · Traditional 03/28/1991SE
K903848Diagnostic Intrascular CatheterDQO · Traditional 03/25/1991SE
K905738Operative Cholangiographic CatheterFGE · Traditional 03/21/1991SE
K910079Disposable Introducer SheathKDC · Traditional 02/27/1991SE
K902256Irrigation Catheter 4, 6 and 10 FrenchDQY · Traditional 02/15/1991SE

Questions and answers

When was Surgical Spring Clips cleared by the FDA?

Surgical Spring Clips (K883909) received a 510(k) decision of Substantially Equivalent on December 27, 1988, 103 days after the submission was received.

What is the product code of K883909?

The FDA product code is DSS – Clip, Vascular, a Class II (moderate risk) device regulated under 21 CFR 870.3250.