Cleared Traditional

K843187 - CANNULA

K843187 is an FDA 510(k) clearance for CANNULA, manufactured by Ethicon, Inc.. The device is a Class 1 General & Plastic Surgery device with product code GEA cleared through the Traditional 510(k) pathway after a 79-day FDA review.

K843187 · Ethicon, Inc. · General & Plastic Surgery device
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Oct 1984
Decision
79d
Days
Class 1
Risk

K843187 is an FDA 510(k) clearance for the CANNULA. Classified as Cannula, Surgical, General & Plastic Surgery (product code GEA), Class I - General Controls.

Submitted by Ethicon, Inc. (Somerville, US). The FDA issued a Cleared decision on October 31, 1984 after a review of 79 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 Ethicon, Inc. devices

FDA 510(k) Submission Details - K843187

510(k) Number K843187 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 13, 1984
Decision Date October 31, 1984
Days to Decision 79 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
36d faster than avg
Panel avg: 115d · This submission: 79d
Pathway characteristics
Predicate-based equivalence.

GEA Device Classification - Class 1, General Controls

Product Code GEA Cannula, Surgical, General & Plastic Surgery
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 - GEA Cannula, Surgical, General & Plastic Surgery

All 17
Devices cleared under the same product code (GEA) and FDA review panel - the closest regulatory comparables to K843187.
NEWMAN CANNULAE SYSTEM (NCS)
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K843468 · Zimmar Consulting , Ltd. · Nov 1984
PADGETT SUCTION CANNULA
K833717 · Advanced Biosearch Assn. · Dec 1983
FRAZIER SUCTION INSTRUMENT-DISPOS
K832636 · Pilling Co. · Oct 1983
MODEL 1301 BIOTAC (TM)
K810627 · Progress Mankind Technology · Apr 1981