Cleared Traditional

CIVCO STEPPER

K871413 · CIVCO Medical Instruments Co., Inc. · General & Plastic Surgery
Jul 1987
Decision
97d
Days
Class 1
Risk

About This 510(k) Submission

K871413 is an FDA 510(k) clearance for the CIVCO STEPPER, a Guide, Surgical, Instrument (Class I — General Controls, product code FZX), submitted by CIVCO Medical Instruments Co., Inc. (Kalona, US). The FDA issued a Cleared decision on July 14, 1987, 97 days after receiving the submission on April 8, 1987. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4800.

Submission Details

510(k) Number K871413 FDA.gov
FDA Decision Cleared SESE
Date Received April 08, 1987
Decision Date July 14, 1987
Days to Decision 97 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary —

Device Classification

Product Code FZX — Guide, Surgical, Instrument
Device Class Class I — General Controls
CFR Regulation 21 CFR 878.4800

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