Cleared Traditional

K844874 - PENNINE LINK YANKAUERS

K844874 is the FDA 510(k) clearance for PENNINE LINK YANKAUERS by Pennine Medical , Ltd.. It is a Class 1 General & Plastic Surgery device (product code GEA) cleared through the Traditional 510(k) pathway after a 171-day FDA review.

K844874 · Pennine Medical , Ltd. · General & Plastic Surgery device
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Jun 1985
Decision
171d
Days
Class 1
Risk

K844874 is an FDA 510(k) clearance for the PENNINE LINK YANKAUERS. Classified as Cannula, Surgical, General & Plastic Surgery (product code GEA), Class I - General Controls.

Submitted by Pennine Medical , Ltd. (Derby, GB). The FDA issued a Cleared decision on June 6, 1985 after a review of 171 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Pennine Medical , Ltd. devices

Submission Details

510(k) Number K844874 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 17, 1984
Decision Date June 06, 1985
Days to Decision 171 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
56d slower than avg
Panel avg: 115d · This submission: 171d
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 K844874.
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