Cleared Traditional

K861070 - COLOPLAST CONVEX RING

K861070 is an FDA 510(k) clearance for COLOPLAST CONVEX RING, manufactured by Coloplast A/S. The device is a Class 1 Gastroenterology & Urology device with product code EXB cleared through the Traditional 510(k) pathway after a 88-day FDA review.

K861070 · Coloplast A/S · Gastroenterology & Urology device
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Jun 1986
Decision
88d
Days
Class 1
Risk

K861070 is an FDA 510(k) clearance for the COLOPLAST CONVEX RING. Classified as Collector, Ostomy (product code EXB), Class I - General Controls.

Submitted by Coloplast A/S (Fort Woth, US). The FDA issued a Cleared decision on June 16, 1986 after a review of 88 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 Coloplast A/S devices

FDA 510(k) Submission Details - K861070

510(k) Number K861070 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 20, 1986
Decision Date June 16, 1986
Days to Decision 88 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
42d faster than avg
Panel avg: 130d · This submission: 88d
Pathway characteristics
Predicate-based equivalence.

EXB Device Classification - Class 1, General Controls

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 69
Devices cleared under the same product code (EXB) and FDA review panel - the closest regulatory comparables to K861070.
SmartBag (SmartPouch)
K181643 · 11 Health Technologies Limited · Nov 2018
CONSEAL COLOSTOMY CONTINENCE SYSTEM (ONE-PIECE)
K881636 · Coloplast A/S · Jul 1988
BARD IRYFIX(TM) STOMA CAP
K862631 · C.R. Bard, Inc. · Oct 1986
DURAHESIVE PROTECTIVE BARRIER WIPE
K855019 · Convatec, A Division of E.R. Squibb & Sons · Apr 1986
MEDI-WIPES UNITED ANTISEPTIC SKIN PREP
K854726 · Pfizer, Inc. · Feb 1986
DURAHESIVE WAFER WITH FLANGE
K855018 · Convatec, A Division of E.R. Squibb & Sons · Feb 1986