Cleared Traditional

K853528 - STAINLESS STEEL & CARBON STEEL STERILE ...

K853528 is the FDA 510(k) clearance for STAINLESS STEEL & CARBON STEEL STERILE ... by Abco Dealers, Inc.. It is a Class 1 General & Plastic Surgery device (product code GES) cleared through the Traditional 510(k) pathway after a 32-day FDA review.

K853528 · Abco Dealers, Inc. · General & Plastic Surgery device
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Sep 1985
Decision
32d
Days
Class 1
Risk

K853528 is an FDA 510(k) clearance for the STAINLESS STEEL & CARBON STEEL STERILE BLADES. Classified as Blade, Scalpel (product code GES), Class I - General Controls.

Submitted by Abco Dealers, Inc. (Milwaukee, US). The FDA issued a Cleared decision on September 24, 1985 after a review of 32 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Abco Dealers, Inc. devices

Submission Details

510(k) Number K853528 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 23, 1985
Decision Date September 24, 1985
Days to Decision 32 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
83d faster than avg
Panel avg: 115d · This submission: 32d
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.

Regulatory Peers - GES Blade, Scalpel

All 8
Devices cleared under the same product code (GES) and FDA review panel - the closest regulatory comparables to K853528.
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
FASCIA CUTTER
K834514 · Stryker Corp. · Mar 1984
H.R. JAKOBI SURG. INSTRUMENTS #11 27/37
K834182 · Imm Enterprises , Ltd. · Jan 1984
JAKOBI SURG. INSTRUMENTS #1 19/10/26
K834194 · Imm Enterprises , Ltd. · Jan 1984