Cleared Traditional

K914715 - PARALLELING GUIDES

K914715 is an FDA 510(k) clearance for PARALLELING GUIDES, manufactured by Implant Corp. of America. The device is a Class 1 General & Plastic Surgery device with product code FZX cleared through the Traditional 510(k) pathway after a 852-day FDA review.

K914715 · Implant Corp. of America · General & Plastic Surgery device
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Feb 1994
Decision
852d
Days
Class 1
Risk

K914715 is an FDA 510(k) clearance for the PARALLELING GUIDES. Classified as Guide, Surgical, Instrument (product code FZX), Class I - General Controls.

Submitted by Implant Corp. of America (St. Petersburg, US). The FDA issued a Cleared decision on February 16, 1994 after a review of 852 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind General & Plastic Surgery submissions.

View all Implant Corp. of America devices

FDA 510(k) Submission Details - K914715

510(k) Number K914715 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 18, 1991
Decision Date February 16, 1994
Days to Decision 852 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
737d slower than avg
Panel avg: 115d · This submission: 852d
Pathway characteristics
Predicate-based equivalence.

FZX Device Classification - Class 1, General Controls

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 13
Devices cleared under the same product code (FZX) and FDA review panel - the closest regulatory comparables to K914715.
CIVCO STEPPER
K871413 · CIVCO Medical Instruments Co., Inc. · Jul 1987
A.C.L. GUIDE KIT
K862564 · Aspen Laboratories, Inc. · Aug 1986
MEADOX SURGIMED BREAST LOCALIZATION WIRE SET/ONLY
K854262 · Meadox Surgimed, Inc. · Dec 1985
NAMIC HOMER MAMMALOK NEEDLE/WIRE LOCALIZER
K852402 · North American Instrument Corp. · Jul 1985
BRITISH SPINAL FUSION SET
K842698 · Downs Surgical , Ltd. · Sep 1984
TECHMEDICA DRILL GUIDE
K841297 · Techmedica, Inc. · Apr 1984