Cleared Traditional

SURGICAL INSTRUMENT KIT, DISPOSABLE (K923176) - FDA 510(k) Clearance

Class I General & Plastic Surgery device.

K923176 · Ulti-Med Intl., Inc. · General & Plastic Surgery device
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Jun 1993
Decision
370d
Days
Class 1
Risk

K923176 is an FDA 510(k) clearance for the SURGICAL INSTRUMENT KIT, DISPOSABLE. Classified as Kit, Surgical Instrument, Disposable (product code KDD), Class I - General Controls.

Submitted by Ulti-Med Intl., Inc. (Glendale Hts., US). The FDA issued a Cleared decision on June 17, 1993 after a review of 370 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Ulti-Med Intl., Inc. devices

Submission Details

510(k) Number K923176 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 12, 1992
Decision Date June 17, 1993
Days to Decision 370 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
255d slower than avg
Panel avg: 115d · This submission: 370d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code KDD Kit, Surgical Instrument, Disposable
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.