Cleared Traditional

K771775 - COLORPLAST TRANSVERSE SYSTEM

K771775 is the FDA 510(k) clearance for COLORPLAST TRANSVERSE SYSTEM by C.R. Bard, Inc.. It is a Class 1 Gastroenterology & Urology device (product code EXB) cleared through the Traditional 510(k) pathway after a 11-day FDA review.

K771775 · C.R. Bard, Inc. · Gastroenterology & Urology device
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Sep 1977
Decision
11d
Days
Class 1
Risk

K771775 is an FDA 510(k) clearance for the COLORPLAST TRANSVERSE SYSTEM. Classified as Collector, Ostomy (product code EXB), Class I - General Controls.

Submitted by C.R. Bard, Inc. (Mchenry, US). The FDA issued a Cleared decision on September 30, 1977 after a review of 11 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5900 - 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 C.R. Bard, Inc. devices

Submission Details

510(k) Number K771775 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 19, 1977
Decision Date September 30, 1977
Days to Decision 11 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
119d faster than avg
Panel avg: 130d · This submission: 11d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code EXB Collector, Ostomy
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 876.5900
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 - EXB Collector, Ostomy

All 55
Devices cleared under the same product code (EXB) and FDA review panel - the closest regulatory comparables to K771775.
HOLLISTER UROSTOMY POUCH
K791534 · Hollister, Inc. · Oct 1979
COLOPLAST CARBON GAS FILTER
K791581 · C.R. Bard, Inc. · Oct 1979
OSTOMY APPLIANCE W/DEODORIZING FILTER
K781373 · Hollister, Inc. · Sep 1978
STOMA BAG W/SKIN BARRIER SEAL RING
K770439 · Hollister, Inc. · Apr 1977
STOMA BAGS W/MICROPOROUS ADHESIVE
K770178 · Hollister, Inc. · Feb 1977
BONGORT ILEOSTOMY POUCH
K760878 · Howmedica Corp. · Dec 1976