Cleared Traditional

K896434 - AUTO SUTURE SURGIPORT CANNULA DIAMETER REDUCER*

K896434 is an FDA 510(k) clearance for AUTO SUTURE SURGIPORT CANNULA DIAMETER ..., manufactured by United States Surgical, A Division of Tyco Healthc. The device is a Class 1 General & Plastic Surgery device with product code GEA cleared through the Traditional 510(k) pathway after a 7-day FDA review.

K896434 · United States Surgical, A Division of Tyco Healthc · General & Plastic Surgery device
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Nov 1989
Decision
7d
Days
Class 1
Risk

K896434 is an FDA 510(k) clearance for the AUTO SUTURE SURGIPORT CANNULA DIAMETER REDUCER*. Classified as Cannula, Surgical, General & Plastic Surgery (product code GEA), Class I - General Controls.

Submitted by United States Surgical, A Division of Tyco Healthc (Norwalk, US). The FDA issued a Cleared decision on November 16, 1989 after a review of 7 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 United States Surgical, A Division of Tyco Healthc devices

FDA 510(k) Submission Details - K896434

510(k) Number K896434 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 09, 1989
Decision Date November 16, 1989
Days to Decision 7 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
108d faster than avg
Panel avg: 115d · This submission: 7d
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 K896434.
DISPOSABLE SPECIMEN BAG W/CANNULA AND INTRODUCER
K911262 · Ethicon, Inc. · Jun 1991
SUCTION SYSTEM
K904218 · Axiom Medical, Inc. · Oct 1990
SOFT SUCTION ADAPTER
K895684 · Applied Medical Technologies · Nov 1989
COOPER SURG ASPIRATION CANNULA/CUSTOM CONVEN PAKS
K872214 · CooperVision, Inc. · Aug 1987
DISPOSABLE SUCTION CANNULA NO. 902008-000
K863293 · Lifestream Int'L, Inc. · Sep 1986
NEWMAN CANNULAE SYSTEM (NCS)
K862936 · Byron Medical · Aug 1986