Cleared Traditional

K915119 - SCALPEL BLADE REMOVER (BLADEGARD)

K915119 is an FDA 510(k) clearance for SCALPEL BLADE REMOVER (BLADEGARD), manufactured by Intergrated Visual, Inc.. The device is a Class 1 General & Plastic Surgery device with product code GES cleared through the Traditional 510(k) pathway after a 174-day FDA review.

K915119 · Intergrated Visual, Inc. · General & Plastic Surgery device
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May 1992
Decision
174d
Days
Class 1
Risk

K915119 is an FDA 510(k) clearance for the SCALPEL BLADE REMOVER (BLADEGARD). Classified as Blade, Scalpel (product code GES), Class I - General Controls.

Submitted by Intergrated Visual, Inc. (Quincy, US). The FDA issued a Cleared decision on May 5, 1992 after a review of 174 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 Intergrated Visual, Inc. devices

FDA 510(k) Submission Details - K915119

510(k) Number K915119 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 13, 1991
Decision Date May 05, 1992
Days to Decision 174 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
59d slower than avg
Panel avg: 115d · This submission: 174d
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 K915119.
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