Cleared Traditional

K950690 - PROSYS URIHESICE SYSTEM NL

K950690 is the FDA 510(k) clearance for PROSYS URIHESICE SYSTEM NL by Convatec, A Division of E.R. Squibb & Sons. It is a Class 1 Gastroenterology & Urology device (product code EXJ) cleared through the Traditional 510(k) pathway after a 37-day FDA review.

K950690 · Convatec, A Division of E.R. Squibb & Sons · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1995
Decision
37d
Days
Class 1
Risk

K950690 is an FDA 510(k) clearance for the PROSYS URIHESICE SYSTEM NL. Classified as Device, Incontinence, Urosheath Type, Sterile (product code EXJ), Class I - General Controls.

Submitted by Convatec, A Division of E.R. Squibb & Sons (Skillman, US). The FDA issued a Cleared decision on March 23, 1995 after a review of 37 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 Convatec, A Division of E.R. Squibb & Sons devices

Submission Details

510(k) Number K950690 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 14, 1995
Decision Date March 23, 1995
Days to Decision 37 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
93d faster than avg
Panel avg: 130d · This submission: 37d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code EXJ Device, Incontinence, Urosheath Type, 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 - EXJ Device, Incontinence, Urosheath Type, Sterile

All 9
Devices cleared under the same product code (EXJ) and FDA review panel - the closest regulatory comparables to K950690.
SELF RETAINING MALE EXTERNAL URINARY CATHETER
K962900 · Hollister, Inc. · Sep 1996
CLEAR ADVANTAGE II
K945628 · Mentor Corp. · Jul 1995
PROSYS URIHESIVE SYSTEM LA
K951530 · Convatec, A Division of E.R. Squibb & Sons · May 1995
CONVEEN(R) SELF-SEALING URISHEATH MALE EXTERNAL CATHETER
K946243 · Coloplast A/S · Feb 1995
HOLLISTER NON-ROLLED SELF-ADHESIVE URINARY EXTERNAL CATHETER
K940269 · Hollister, Inc. · Jun 1994
CONVEEN(R) SELF-SEALING URISHEATH MALE EXTER CATH
K924407 · Coloplast A/S · Sep 1992