Cleared Traditional

K971499 - FEMALE EXTERNAL URINARY COLLECTION POUCH

K971499 is the FDA 510(k) clearance for FEMALE EXTERNAL URINARY COLLECTION POUCH by Mediquest, Inc.. It is a Class 1 Gastroenterology & Urology device (product code EXI) cleared through the Traditional 510(k) pathway after a 125-day FDA review.

K971499 · Mediquest, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1997
Decision
125d
Days
Class 1
Risk

K971499 is an FDA 510(k) clearance for the FEMALE EXTERNAL URINARY COLLECTION POUCH. Classified as Device, Paste-on For Incontinence, Sterile (product code EXI), Class I - General Controls.

Submitted by Mediquest, Inc. (Irvine, US). The FDA issued a Cleared decision on August 28, 1997 after a review of 125 days - within the typical 510(k) review window.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5250 - 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 Mediquest, Inc. devices

Submission Details

510(k) Number K971499 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 25, 1997
Decision Date August 28, 1997
Days to Decision 125 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
5d faster than avg
Panel avg: 130d · This submission: 125d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code EXI Device, Paste-on For Incontinence, Sterile
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 876.5250
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 - EXI Device, Paste-on For Incontinence, Sterile

Devices cleared under the same product code (EXI) and FDA review panel - the closest regulatory comparables to K971499.
HOLLISTER RETRACTED PENIS POUCH
K970443 · Hollister, Inc. · Feb 1997
HOLLISTER PREMIUM URINE COLLECTOR
K931277 · Hollister, Inc. · Jun 1993
CONVATEC LITTLE ONES PEDIATRIC URINE COLLECTION
K924755 · Convatec, A Division of E.R. Squibb & Sons · Jun 1993
CONVEEN(R) URISHEATH AND URILINER(MALE EXTER CATH)
K915246 · Coloplast A/S · Feb 1992
URIHESIVE STRIP
K915616 · Convatec, A Division of E.R. Squibb & Sons · Jan 1992