Cleared Traditional

K862576 - PS2 BRAND FACIAL SYMMETRY GUIDE (LEE DESIGN)

K862576 is an FDA 510(k) clearance for PS2 BRAND FACIAL SYMMETRY GUIDE (LEE DE..., manufactured by Professional Services For Surgeons, Ltd.. The device is a Class 1 General & Plastic Surgery device with product code FTY cleared through the Traditional 510(k) pathway after a 8-day FDA review.

K862576 · Professional Services For Surgeons, Ltd. · General & Plastic Surgery device
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Jul 1986
Decision
8d
Days
Class 1
Risk

K862576 is an FDA 510(k) clearance for the PS2 BRAND FACIAL SYMMETRY GUIDE (LEE DESIGN). Classified as Tape, Measuring, Rulers And Calipers (product code FTY), Class I - General Controls.

Submitted by Professional Services For Surgeons, Ltd. (Midland, US). The FDA issued a Cleared decision on July 15, 1986 after a review of 8 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 Professional Services For Surgeons, Ltd. devices

FDA 510(k) Submission Details - K862576

510(k) Number K862576 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 07, 1986
Decision Date July 15, 1986
Days to Decision 8 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
107d faster than avg
Panel avg: 115d · This submission: 8d
Pathway characteristics
Predicate-based equivalence.

FTY Device Classification - Class 1, General Controls

Product Code FTY Tape, Measuring, Rulers And Calipers
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 - FTY Tape, Measuring, Rulers And Calipers

All 11
Devices cleared under the same product code (FTY) and FDA review panel - the closest regulatory comparables to K862576.
OLYMPIC INFA-LENGTH
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STRYKER PRESSURE MONITOR SYSTEM
K883485 · Stryker Corp. · Sep 1988
LN 100 BREAST MARKER
K872319 · Instrumentation Industries, Inc. · Aug 1987
ZIMMER OSSIMETER
K832899 · Zimmer, Inc. · Oct 1983
SAGITTAL KNEE TESTER
K831041 · Orthopedic Systems, Inc. · Jun 1983
EXTENDED TUMOR CALIPER
K811278 · Mick Radio-Nuclear Instruments, Inc. · Jun 1981