Cleared Traditional

K970716 - OPTICON DIRECT MALE URINARY CATHETER FOR CONTINUOUS DRAINAGE

K970716 is an FDA 510(k) clearance for OPTICON DIRECT MALE URINARY CATHETER FO..., manufactured by Opticon Medical, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code EZL cleared through the Traditional 510(k) pathway after a 78-day FDA review.

K970716 · Opticon Medical, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1997
Decision
78d
Days
Class 2
Risk

K970716 is an FDA 510(k) clearance for the OPTICON DIRECT MALE URINARY CATHETER FOR CONTINUOUS DRAINAGE. Classified as Catheter, Retention Type, Balloon (product code EZL), Class II - Special Controls.

Submitted by Opticon Medical, Inc. (Minneapolis, US). The FDA issued a Cleared decision on May 16, 1997 after a review of 78 days - a notably fast clearance 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: 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 Opticon Medical, Inc. devices

FDA 510(k) Submission Details - K970716

510(k) Number K970716 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 27, 1997
Decision Date May 16, 1997
Days to Decision 78 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
53d faster than avg
Panel avg: 131d · This submission: 78d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EZL Device Classification - Class 2, Special Controls

Product Code EZL Catheter, Retention Type, Balloon
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 - EZL Catheter, Retention Type, Balloon

All 95
Devices cleared under the same product code (EZL) and FDA review panel - the closest regulatory comparables to K970716.
LAPAROTOMY BLADDER NECK SUSPENSION KIT WITH BONE ANCHORS
K971796 · Louisville Laboratories, Inc. · Aug 1997
LAPAROTOMY BLADDER NECK SUSPENSION KIT
K971801 · Louisville Laboratories, Inc. · Jul 1997
CONTIDRAIN CATHETER
K964757 · Contimed, Inc. · Jun 1997
SYMPACATH HYDROGEL COATED FOLEY
K964575 · Rusch Intl. · Feb 1997
OPTICON FEMALE URINARY INCONTINENCE CATHETER FOR CONTINUOUS DRAINAGE
K961697 · Medical Device Intl., Inc. · Aug 1996
MRI'S ALL SILICONE FOLEY CATHETER TEMPERATURE PROBE
K944673 · Regulatory & Marketing Services, Inc. · Apr 1996