Civco Stepper

FDA 510(k) K871413 · CIVCO Medical Instruments Co., Inc.

Substantially Equivalent

510(k) numberK871413

Submission

Device name
Civco Stepper
Applicant
CIVCO Medical Instruments Co., Inc.
Kalona, IA, US
Received
April 8, 1987
Decision date
July 14, 1987
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
FZX – Guide, Surgical, Instrument
Device class
Class I (low risk)
Regulation
21 CFR 878.4800
Specialty
General, Plastic Surgery

Other 510(k)s with product code FZX

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K914715Paralleling GuidesFZX · Traditional Implant Corp. of America02/16/1994SE
K871503Biopsy Needle Guide Kit, SterileFZX · Traditional Amedic USA07/10/1987SE
K862564A.C.L. Guide KitFZX · Traditional Aspen Laboratories, Inc.08/18/1986SE
K854262Meadox Surgimed Breast Localization Wire Set/OnlyFZX · Traditional Meadox Surgimed, Inc.12/24/1985SE
K852402Namic Homer Mammalok Needle/Wire LocalizerFZX · Traditional North American Instrument Corp.07/11/1985SE
K842698British Spinal Fusion SetFZX · Traditional Downs Surgical , Ltd.09/12/1984SE
K841618Threading TubeFZX · Traditional Plastafil, Inc.08/27/1984SE
K841619Drill GuideFZX · Traditional Plastafil, Inc.07/11/1984SE
K841297Techmedica Drill GuideFZX · Traditional Techmedica, Inc.04/25/1984SE
K840835Straith Drain InserterFZX · Traditional Surgical Technology Laboratories, Inc.04/23/1984SE

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Questions and answers

When was Civco Stepper cleared by the FDA?

Civco Stepper (K871413) received a 510(k) decision of Substantially Equivalent on July 14, 1987, 97 days after the submission was received.

What is the product code of K871413?

The FDA product code is FZX – Guide, Surgical, Instrument, a Class I (low risk) device regulated under 21 CFR 878.4800.