Storz Raney Scalp Clip, Model 1-20-004-05

FDA 510(k) K033660 · Rudolf Storz GmbH

Substantially Equivalent

510(k) numberK033660

Submission

Device name
Storz Raney Scalp Clip, Model 1-20-004-05
Applicant
Rudolf Storz GmbH
Amsterdam, NL
Received
November 21, 2003
Decision date
January 7, 2004
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
HBO – Clip, Scalp
Device class
Class II (moderate risk)
Regulation
21 CFR 882.4150
Specialty
Neurology

Other 510(k)s with product code HBO

510(k)DeviceApplicantDecision
K253814Raney Clips KitHBO · Traditional Beijing Honghugaoxiang Science and Technology…07/21/2026SE
K050044Medtronic Clip Gun KitHBO · Special Medtronic Neurosurgery02/07/2005SE
K012219Scalpfix Clip SystemHBO · Special Aesculap, Inc.07/31/2001SE
K944311Acra-CutHBO · Traditional Acra Cut, Inc.11/18/1994SE
K905433Codman Disposable Scalp Clip ApplierHBO · Traditional Codman & Shurtleff, Inc.02/21/1991SE
K896723Clip Gun with Raney Type Scalp ClipsHBO · Traditional Omni Medical Designs03/23/1990SE
K894778Codman RF-12 Disposable Scalp Clip ApplierHBO · Traditional Codman & Shurtleff, Inc.12/06/1989SE
K890443Caspar Scalp Clip, ApplierHBO · Traditional Aesculap Instruments Corp.06/15/1989SE
K883963Raney and Leroy-Raney Scalp ClipHBO · Traditional New England Surgical Instrument Corp.10/07/1988SE
K881265Raney ClipsHBO · Traditional Zimmer, Inc.05/31/1988SE

Questions and answers

When was Storz Raney Scalp Clip, Model 1-20-004-05 cleared by the FDA?

Storz Raney Scalp Clip, Model 1-20-004-05 (K033660) received a 510(k) decision of Substantially Equivalent on January 7, 2004, 47 days after the submission was received.

What is the product code of K033660?

The FDA product code is HBO – Clip, Scalp, a Class II (moderate risk) device regulated under 21 CFR 882.4150.