Cleared Traditional

K871413 - CIVCO STEPPER

K871413 is the FDA 510(k) clearance for CIVCO STEPPER by CIVCO Medical Instruments Co., Inc.. It is a Class 1 General & Plastic Surgery device (product code FZX) cleared through the Traditional 510(k) pathway after a 97-day FDA review.

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

K871413 is an FDA 510(k) clearance for the CIVCO STEPPER. Classified as Guide, Surgical, Instrument (product code FZX), Class I - General Controls.

Submitted by CIVCO Medical Instruments Co., Inc. (Kalona, US). The FDA issued a Cleared decision on July 14, 1987 after a review of 97 days - within the typical 510(k) review window.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4800 - the FDA general and plastic surgery device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all CIVCO Medical Instruments Co., Inc. devices

Submission Details

510(k) Number K871413 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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 -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
18d faster than avg
Panel avg: 115d · This submission: 97d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code FZX Guide, Surgical, Instrument
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4800
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - FZX Guide, Surgical, Instrument

All 8
Devices cleared under the same product code (FZX) and FDA review panel - the closest regulatory comparables to K871413.
A.C.L. GUIDE KIT
K862564 · Aspen Laboratories, Inc. · Aug 1986
BRITISH SPINAL FUSION SET
K842698 · Downs Surgical , Ltd. · Sep 1984
TECHMEDICA DRILL GUIDE
K841297 · Techmedica, Inc. · Apr 1984
ACUFEX DREZ COMMUNICATING DRILL GUIDE
K834350 · Acufex Microsurgical, Inc. · Mar 1984
GRAF MENISCAL SUTURE SET
K830720 · Acufex Microsurgical, Inc. · Jun 1983
GABBAY-FRATER SUTURE GUIDE
K802093 · Howmedica Corp. · Sep 1980