Cleared Traditional

K842774 - CODMAN SUCTION PUNCH-PRODUCT CODES

K842774 is an FDA 510(k) clearance for CODMAN SUCTION PUNCH-PRODUCT CODES, manufactured by Codman & Shurtleff, Inc.. The device is a Class 1 General & Plastic Surgery device with product code HTZ cleared through the Traditional 510(k) pathway after a 11-day FDA review.

K842774 · Codman & Shurtleff, Inc. · General & Plastic Surgery device
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Jul 1984
Decision
11d
Days
Class 1
Risk

K842774 is an FDA 510(k) clearance for the CODMAN SUCTION PUNCH-PRODUCT CODES. Classified as Instrument, Cutting, Orthopedic (product code HTZ), Class I - General Controls.

Submitted by Codman & Shurtleff, Inc. (Walker, US). The FDA issued a Cleared decision on July 27, 1984 after a review of 11 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 Codman & Shurtleff, Inc. devices

FDA 510(k) Submission Details - K842774

510(k) Number K842774 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 16, 1984
Decision Date July 27, 1984
Days to Decision 11 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
104d faster than avg
Panel avg: 115d · This submission: 11d
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 14
Devices cleared under the same product code (HTZ) and FDA review panel - the closest regulatory comparables to K842774.
CONCEPT SUCTION SLEEVE
K850423 · Concept, Inc. · Mar 1985
ARTHROSCOPY SUCTION BIOPSY PUNCH
K850527 · T. Korossurgical Instruments Corp. · Mar 1985
SIDE CUTTING SERRATED BLADE
K841980 · Stainless Mfg., Inc. · Aug 1984
BANANA KNIFE - K841969-LABELING
K841972 · Stainless Mfg., Inc. · Jun 1984
BANANA KNIFE SERRATED
K841973 · Stainless Mfg., Inc. · Jun 1984
RETROGRADE KNIFE 4MM & 5MM
K841974 · Stainless Mfg., Inc. · Jun 1984