Cleared Traditional

K951945 - PROSYS LEG BAG

K951945 is the FDA 510(k) clearance for PROSYS LEG BAG by Convatec, A Division of E.R. Squibb & Sons. It is a Class 1 Gastroenterology & Urology device (product code FAQ) cleared through the Traditional 510(k) pathway after a 29-day FDA review.

K951945 · Convatec, A Division of E.R. Squibb & Sons · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1995
Decision
29d
Days
Class 1
Risk

K951945 is an FDA 510(k) clearance for the PROSYS LEG BAG. Classified as Bag, Urine Collection, Leg, For External Use, Sterile (product code FAQ), Class I - General Controls.

Submitted by Convatec, A Division of E.R. Squibb & Sons (Princeton, US). The FDA issued a Cleared decision on May 25, 1995 after a review of 29 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 K951945 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 26, 1995
Decision Date May 25, 1995
Days to Decision 29 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
101d faster than avg
Panel avg: 130d · This submission: 29d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code FAQ Bag, Urine Collection, Leg, For External Use, 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 - FAQ Bag, Urine Collection, Leg, For External Use, Sterile

All 9
Devices cleared under the same product code (FAQ) and FDA review panel - the closest regulatory comparables to K951945.
CONVEEN URINE BAG - STERILE
K955609 · Coloplast Corp. · Dec 1995
PROSYS BEDSIDE DRAINAGE BAG
K953767 · Convatec, A Division of E.R. Squibb & Sons · Dec 1995
CONVEEN LEG BAG STRAP
K953783 · Coloplast Corp. · Sep 1995
BARD LEG BAG HOLDER
K926035 · C.R. Bard, Inc. · Dec 1992
CONVEEN(R) LEG BAG(500 ML)
K924406 · Coloplast A/S · Oct 1992
EXTERNAL LEG BAG
K901219 · Orion Life Systems, Inc. · Jun 1990