Cleared Traditional

K802093 - GABBAY-FRATER SUTURE GUIDE

K802093 is an FDA 510(k) clearance for GABBAY-FRATER SUTURE GUIDE, manufactured by Howmedica Corp.. The device is a Class 1 General & Plastic Surgery device with product code FZX cleared through the Traditional 510(k) pathway after a 24-day FDA review.

K802093 · Howmedica Corp. · General & Plastic Surgery device
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Sep 1980
Decision
24d
Days
Class 1
Risk

K802093 is an FDA 510(k) clearance for the GABBAY-FRATER SUTURE GUIDE. Classified as Guide, Surgical, Instrument (product code FZX), Class I - General Controls.

Submitted by Howmedica Corp. (Mchenry, US). The FDA issued a Cleared decision on September 26, 1980 after a review of 24 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 Howmedica Corp. devices

FDA 510(k) Submission Details - K802093

510(k) Number K802093 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 02, 1980
Decision Date September 26, 1980
Days to Decision 24 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
91d faster than avg
Panel avg: 115d · This submission: 24d
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 12
Devices cleared under the same product code (FZX) and FDA review panel - the closest regulatory comparables to K802093.
GRAF MENISCAL SUTURE SET
K830720 · Acufex Microsurgical, Inc. · Jun 1983
DISPOSABLE NEEDLE HOLDERS
K821618 · Medcare Products · Jun 1982
BOUNDARY TUBING HOLDERS
K810888 · The Buckeye Cellulose Corp. · Apr 1981
FEEDING TUBE PLACEMENT STYLET
K792468 · Biosearch Medical Products, Inc. · Dec 1979
ENTERIC TUBE GUIDE
K790872 · Biosearch Medical Products, Inc. · May 1979