Cleared Traditional

K932143 - FLEXI-TRAK ANCHORING DEVICE

K932143 is the FDA 510(k) clearance for FLEXI-TRAK ANCHORING DEVICE by Convatec, A Division of E.R. Squibb & Sons. It is a Class 2 Gastroenterology & Urology device (product code KNY) cleared through the Traditional 510(k) pathway after a 215-day FDA review.

K932143 · Convatec, A Division of E.R. Squibb & Sons · Gastroenterology & Urology device
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Optimized for regulatory review, auditing and printing
Dec 1993
Decision
215d
Days
Class 2
Risk

K932143 is an FDA 510(k) clearance for the FLEXI-TRAK ANCHORING DEVICE. Classified as Accessories, Catheter, G-u (product code KNY), Class II - Special Controls.

Submitted by Convatec, A Division of E.R. Squibb & Sons (Princeton, US). The FDA issued a Cleared decision on December 1, 1993 after a review of 215 days - an extended review cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5130 - the FDA gastroenterology and urology 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 Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

View all Convatec, A Division of E.R. Squibb & Sons devices

Submission Details

510(k) Number K932143 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 30, 1993
Decision Date December 01, 1993
Days to Decision 215 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
85d slower than avg
Panel avg: 130d · This submission: 215d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KNY Accessories, Catheter, G-u
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5130
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 Gastroenterology & Urology devices follow this clearance model.

Regulatory Peers - KNY Accessories, Catheter, G-u

All 19
Devices cleared under the same product code (KNY) and FDA review panel - the closest regulatory comparables to K932143.
AMPLATZ SUPER STIFF GUIDEWIRE
K944754 · Boston Scientific Corp · Oct 1994
UROLOGICAL GUIDWIRE
K944135 · Applied Medical Resources · Sep 1994
ZEBRA UROLOGICAL GUIDEWIRE
K942205 · Boston Scientific Corp · Jul 1994
URINARY CARE SUPPLIES
K923496 · Orion Life Systems, Inc. · May 1993
GUIDEWIRE
K921200 · Lake Region Mfg., Inc. · Sep 1992
KENDALL CURITY KIDS PEDIATRIC DRAINAGE ADAPTER
K921055 · Kendall Healthcare Products Co. Div.Of Tyco Health · May 1992