Cleared Traditional

K862564 - A.C.L. GUIDE KIT

K862564 is an FDA 510(k) clearance for A.C.L. GUIDE KIT, manufactured by Aspen Laboratories, Inc.. The device is a Class 1 General & Plastic Surgery device with product code FZX cleared through the Traditional 510(k) pathway after a 46-day FDA review.

K862564 · Aspen Laboratories, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1986
Decision
46d
Days
Class 1
Risk

K862564 is an FDA 510(k) clearance for the A.C.L. GUIDE KIT. Classified as Guide, Surgical, Instrument (product code FZX), Class I - General Controls.

Submitted by Aspen Laboratories, Inc. (Englewood, US). The FDA issued a Cleared decision on August 18, 1986 after a review of 46 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Aspen Laboratories, Inc. devices

FDA 510(k) Submission Details - K862564

510(k) Number K862564 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 03, 1986
Decision Date August 18, 1986
Days to Decision 46 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
69d faster than avg
Panel avg: 115d · This submission: 46d
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 10
Devices cleared under the same product code (FZX) and FDA review panel - the closest regulatory comparables to K862564.
CIVCO STEPPER
K871413 · CIVCO Medical Instruments Co., Inc. · Jul 1987
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
ACUFEX DREZ COMMUNICATING DRILL GUIDE
K834350 · Acufex Microsurgical, Inc. · Mar 1984