Cleared Traditional

K923170 - LOS ALAMOS RETRACTABLE KNIFE

K923170 is an FDA 510(k) clearance for LOS ALAMOS RETRACTABLE KNIFE, manufactured by Innovative Surgical Technology, Inc.. The device is a Class 1 General & Plastic Surgery device with product code GES cleared through the Traditional 510(k) pathway after a 234-day FDA review.

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

FDA 510(k) Submission Details - K923170

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.

GES Device Classification - Class 1, General Controls

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.

Regulatory Peers - GES Blade, Scalpel

All 11
Devices cleared under the same product code (GES) and FDA review panel - the closest regulatory comparables to K923170.
EASY-ON
K932998 · Devon Industries, Inc. · Aug 1993
PRECISION GLIDE - ENHANCED SURGICAL BLADE
K911913 · Bd Becton Dickinson Vacutainer Systems Preanalytic · May 1991
DEXTRA DISPOSABLE BLADES
K863867 · Storz Instrument Co. · Oct 1986
ANGIOMED SKIN FASCIA KNIFE
K855104 · Angiomed U.S., Inc. · Jan 1986
STAINLESS STEEL & CARBON STEEL STERILE BLADES
K853528 · Abco Dealers, Inc. · Sep 1985
FASCIA CUTTER
K834514 · Stryker Corp. · Mar 1984