Cleared Traditional

K864425 - RAYLOR(TM) DISSECTING HOOK

K864425 is an FDA 510(k) clearance for RAYLOR(TM) DISSECTING HOOK, manufactured by Cedar Surgical, Inc.. The device is a Class 1 General & Plastic Surgery device with product code GDG cleared through the Traditional 510(k) pathway after a 32-day FDA review.

K864425 · Cedar Surgical, Inc. · General & Plastic Surgery device
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Dec 1986
Decision
32d
Days
Class 1
Risk

K864425 is an FDA 510(k) clearance for the RAYLOR(TM) DISSECTING HOOK. Classified as Hook, Surgical, General & Plastic Surgery (product code GDG), Class I - General Controls.

Submitted by Cedar Surgical, Inc. (Minnetonka, US). The FDA issued a Cleared decision on December 12, 1986 after a review of 32 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 Cedar Surgical, Inc. devices

FDA 510(k) Submission Details - K864425

510(k) Number K864425 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 10, 1986
Decision Date December 12, 1986
Days to Decision 32 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
83d faster than avg
Panel avg: 115d · This submission: 32d
Pathway characteristics
Predicate-based equivalence.

GDG Device Classification - Class 1, General Controls

Product Code GDG Hook, Surgical, General & Plastic Surgery
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 - GDG Hook, Surgical, General & Plastic Surgery

All 7
Devices cleared under the same product code (GDG) and FDA review panel - the closest regulatory comparables to K864425.
MODIFIED PGL ABSORBABLE STAPLE*
K900069 · United States Surgical, A Division of Tyco Healthc · Apr 1990
SKIN HOOKS, VARIOUS TYPES
K891898 · Zinnanti Surgical Instruments, Inc. · Apr 1989
SURGICAL HOOKS, VARIOUS
K841010 · Premier Dental Products Co. · May 1984
MIDDLE EAR PICKS, HOOKS CURETTES,
K791120 · Xomed, Inc. · Jul 1979
NERVE APPROXIMATER
K780289 · Edward Weck, Inc. · Jun 1978
DERMAHOOK #382-805
K771187 · Edward Weck, Inc. · Jul 1977