Cleared Traditional

K832978 - MENISCAL SUTURE GUN (FDA 510(k) Clearance)

Class I General & Plastic Surgery device.

K832978 · Instrument Makar, Inc. · General & Plastic Surgery device
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Dec 1983
Decision
101d
Days
Class 1
Risk

K832978 is an FDA 510(k) clearance for the MENISCAL SUTURE GUN. Classified as Guide, Needle, Surgical (product code GDF), Class I - General Controls.

Submitted by Instrument Makar, Inc. (Mchenry, US). The FDA issued a Cleared decision on December 12, 1983 after a review of 101 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 Instrument Makar, Inc. devices

Submission Details

510(k) Number K832978 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 02, 1983
Decision Date December 12, 1983
Days to Decision 101 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
13d faster than avg
Panel avg: 114d · This submission: 101d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code GDF Guide, Needle, Surgical
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.