Cleared Traditional

K830720 - GRAF MENISCAL SUTURE SET

K830720 is the FDA 510(k) clearance for GRAF MENISCAL SUTURE SET by Acufex Microsurgical, Inc.. It is a Class 1 General & Plastic Surgery device (product code FZX) cleared through the Traditional 510(k) pathway after a 100-day FDA review.

K830720 · Acufex Microsurgical, Inc. · General & Plastic Surgery device
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Jun 1983
Decision
100d
Days
Class 1
Risk

K830720 is an FDA 510(k) clearance for the GRAF MENISCAL SUTURE SET. Classified as Guide, Surgical, Instrument (product code FZX), Class I - General Controls.

Submitted by Acufex Microsurgical, Inc. (Mchenry, US). The FDA issued a Cleared decision on June 16, 1983 after a review of 100 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Acufex Microsurgical, Inc. devices

Submission Details

510(k) Number K830720 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 08, 1983
Decision Date June 16, 1983
Days to Decision 100 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
15d faster than avg
Panel avg: 115d · This submission: 100d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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

Devices cleared under the same product code (FZX) and FDA review panel - the closest regulatory comparables to K830720.
A.C.L. GUIDE KIT
K862564 · Aspen Laboratories, Inc. · Aug 1986
BRITISH SPINAL FUSION SET
K842698 · Downs Surgical , Ltd. · Sep 1984
ACUFEX DREZ COMMUNICATING DRILL GUIDE
K834350 · Acufex Microsurgical, Inc. · Mar 1984
GABBAY-FRATER SUTURE GUIDE
K802093 · Howmedica Corp. · Sep 1980
FEEDING TUBE PLACEMENT STYLET
K792468 · Biosearch Medical Products, Inc. · Dec 1979
ENTERIC TUBE GUIDE
K790872 · Biosearch Medical Products, Inc. · May 1979