Cleared Traditional

K970443 - HOLLISTER RETRACTED PENIS POUCH

K970443 is an FDA 510(k) clearance for HOLLISTER RETRACTED PENIS POUCH, manufactured by Hollister, Inc.. The device is a Class 1 Gastroenterology & Urology device with product code EXI cleared through the Traditional 510(k) pathway after a 20-day FDA review.

K970443 · Hollister, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1997
Decision
20d
Days
Class 1
Risk

K970443 is an FDA 510(k) clearance for the HOLLISTER RETRACTED PENIS POUCH. Classified as Device, Paste-on For Incontinence, Sterile (product code EXI), Class I - General Controls.

Submitted by Hollister, Inc. (Libertyville, US). The FDA issued a Cleared decision on February 25, 1997 after a review of 20 days - a notably fast clearance cycle.

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: 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 Hollister, Inc. devices

FDA 510(k) Submission Details - K970443

510(k) Number K970443 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 05, 1997
Decision Date February 25, 1997
Days to Decision 20 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
110d faster than avg
Panel avg: 130d · This submission: 20d
Pathway characteristics
Predicate-based equivalence.

EXI Device Classification - Class 1, General Controls

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 K970443.
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