Cleared Traditional

LOS ALAMOS RETRACTABLE KNIFE (K923170) - FDA 510(k) Clearance

Class I General & Plastic Surgery device.

K923170 · Innovative Surgical Technology, Inc. · General & Plastic Surgery device
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Feb 1993
Decision
234d
Days
Class 1
Risk

K923170 is an FDA 510(k) clearance for the LOS ALAMOS RETRACTABLE KNIFE. Classified as Blade, Scalpel (product code GES), Class I - General Controls.

Submitted by Innovative Surgical Technology, Inc. (Los Alamos, US). The FDA issued a Cleared decision on February 18, 1993 after a review of 234 days - an extended review 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: 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 Innovative Surgical Technology, Inc. devices

Submission Details

510(k) Number K923170 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 29, 1992
Decision Date February 18, 1993
Days to Decision 234 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
119d slower than avg
Panel avg: 115d · This submission: 234d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code GES Blade, Scalpel
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.