Cleared Traditional

K843468 - PHARMA-PLAST SUCTION SET TYPE YANKAUER

K843468 is the FDA 510(k) clearance for PHARMA-PLAST SUCTION SET TYPE YANKAUER by Zimmar Consulting , Ltd.. It is a Class 1 General & Plastic Surgery device (product code GEA) cleared through the Traditional 510(k) pathway after a 78-day FDA review.

K843468 · Zimmar Consulting , Ltd. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1984
Decision
78d
Days
Class 1
Risk

K843468 is an FDA 510(k) clearance for the PHARMA-PLAST SUCTION SET TYPE YANKAUER. Classified as Cannula, Surgical, General & Plastic Surgery (product code GEA), Class I - General Controls.

Submitted by Zimmar Consulting , Ltd. (Mchenry, US). The FDA issued a Cleared decision on November 23, 1984 after a review of 78 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 Zimmar Consulting , Ltd. devices

Submission Details

510(k) Number K843468 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 06, 1984
Decision Date November 23, 1984
Days to Decision 78 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
37d faster than avg
Panel avg: 115d · This submission: 78d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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 7
Devices cleared under the same product code (GEA) and FDA review panel - the closest regulatory comparables to K843468.
DISPOSABLE SPECIMEN BAG W/CANNULA AND INTRODUCER
K911262 · Ethicon, Inc. · Jun 1991
AUTO SUTURE SURGIPORT CANNULA DIAMETER REDUCER*
K896434 · United States Surgical, A Division of Tyco Healthc · Nov 1989
COOPER SURG ASPIRATION CANNULA/CUSTOM CONVEN PAKS
K872214 · CooperVision, Inc. · Aug 1987
CANNULA
K843187 · Ethicon, Inc. · Oct 1984