Cleared Traditional

K841980 - SIDE CUTTING SERRATED BLADE

K841980 is an FDA 510(k) clearance for SIDE CUTTING SERRATED BLADE, manufactured by Stainless Mfg., Inc.. The device is a Class 1 General & Plastic Surgery device with product code HTZ cleared through the Traditional 510(k) pathway after a 93-day FDA review.

K841980 · Stainless Mfg., Inc. · General & Plastic Surgery device
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Aug 1984
Decision
93d
Days
Class 1
Risk

K841980 is an FDA 510(k) clearance for the SIDE CUTTING SERRATED BLADE. Classified as Instrument, Cutting, Orthopedic (product code HTZ), Class I - General Controls.

Submitted by Stainless Mfg., Inc. (Mchenry, US). The FDA issued a Cleared decision on August 15, 1984 after a review of 93 days - within the typical 510(k) review window.

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 Stainless Mfg., Inc. devices

FDA 510(k) Submission Details - K841980

510(k) Number K841980 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 14, 1984
Decision Date August 15, 1984
Days to Decision 93 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
22d faster than avg
Panel avg: 115d · This submission: 93d
Pathway characteristics
Predicate-based equivalence.

HTZ Device Classification - Class 1, General Controls

Product Code HTZ Instrument, Cutting, Orthopedic
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 - HTZ Instrument, Cutting, Orthopedic

All 13
Devices cleared under the same product code (HTZ) and FDA review panel - the closest regulatory comparables to K841980.
KAMBIN SPINAL INSTRUMENT SET
K853678 · Pilling Co. · Sep 1985
CONCEPT SUCTION SLEEVE
K850423 · Concept, Inc. · Mar 1985
ARTHROSCOPY SUCTION BIOPSY PUNCH
K850527 · T. Korossurgical Instruments Corp. · Mar 1985
CODMAN SUCTION PUNCH-PRODUCT CODES
K842774 · Codman & Shurtleff, Inc. · Jul 1984
BANANA KNIFE - K841969-LABELING
K841972 · Stainless Mfg., Inc. · Jun 1984
BANANA KNIFE SERRATED
K841973 · Stainless Mfg., Inc. · Jun 1984