Cleared Traditional

K843034 - DISPOSABLE LINEAR CUTTER

K843034 is an FDA 510(k) clearance for DISPOSABLE LINEAR CUTTER, manufactured by Ethicon, Inc.. The device is a Class 2 General & Plastic Surgery device with product code GDW cleared through the Traditional 510(k) pathway after a 47-day FDA review.

K843034 · Ethicon, Inc. · General & Plastic Surgery device
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Sep 1984
Decision
47d
Days
Class 2
Risk

K843034 is an FDA 510(k) clearance for the DISPOSABLE LINEAR CUTTER. Classified as Staple, Implantable (product code GDW), Class II - Special Controls.

Submitted by Ethicon, Inc. (Walker, US). The FDA issued a Cleared decision on September 17, 1984 after a review of 47 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4750 - 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.

FDA 510(k) Submission Details - K843034

510(k) Number K843034 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 01, 1984
Decision Date September 17, 1984
Days to Decision 47 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
68d faster than avg
Panel avg: 115d · This submission: 47d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GDW Device Classification - Class 2, Special Controls

Product Code GDW Staple, Implantable
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4750
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General & Plastic Surgery devices follow this clearance model.

Regulatory Peers - GDW Staple, Implantable

All 284
Devices cleared under the same product code (GDW) and FDA review panel - the closest regulatory comparables to K843034.
PI-PNEUMO INTESTINAL STAPLING CARTRIDGE
K851122 · Surgeons Choice, Inc. · Apr 1985
SURGEONS CHOICE PI VASCULAR STAPLING
K843399 · Surgeons Choice, Inc. · Nov 1984
AUTO SUTURE POLY GIA SURGICAL STAPLER
K843603 · United States Surgical, A Division of Tyco Healthc · Oct 1984
AMER. V. MUELLER SURG. STAPLES ILA
K833698 · American Heyer Schulte · Jan 1984
AMER. V. MUELLER SURGICALSTAPLES-CARTR
K833704 · American Heyer Schulte · Dec 1983
APPOSE SKIN STAPLER & REMOVER
K823552 · American Cyanamid Co. · Jun 1983
K843034 · DISPOSABLE LINEAR CUTTER
Download PDF Ethicon, Inc.