Cleared Traditional

K842398 - SUR-FIT IRRIGATION ADAPTER FACEPLATE

K842398 is the FDA 510(k) clearance for SUR-FIT IRRIGATION ADAPTER FACEPLATE by Convatec, A Division of E.R. Squibb & Sons. It is a Class 1 Gastroenterology & Urology device (product code EXB) cleared through the Traditional 510(k) pathway after a 104-day FDA review.

K842398 · Convatec, A Division of E.R. Squibb & Sons · Gastroenterology & Urology device
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Oct 1984
Decision
104d
Days
Class 1
Risk

K842398 is an FDA 510(k) clearance for the SUR-FIT IRRIGATION ADAPTER FACEPLATE. Classified as Collector, Ostomy (product code EXB), Class I - General Controls.

Submitted by Convatec, A Division of E.R. Squibb & Sons (Mchenry, US). The FDA issued a Cleared decision on October 1, 1984 after a review of 104 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

View all Convatec, A Division of E.R. Squibb & Sons devices

Submission Details

510(k) Number K842398 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 19, 1984
Decision Date October 01, 1984
Days to Decision 104 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
26d faster than avg
Panel avg: 130d · This submission: 104d
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 65
Devices cleared under the same product code (EXB) and FDA review panel - the closest regulatory comparables to K842398.
COLOPLAST URO 2002 UROSTOMY SYSTEM
K844685 · Coloplast A/S · Jan 1985
UNITED SKIN BARRIERS
K844046 · Howmedica Corp. · Nov 1984
JOHNSON & JOHN SON OSTOMY PASTE PROTECTIVWE SKIN
K844406 · Johnson & Johnson Professionals, Inc. · Nov 1984
COMFEEL PROTECTIVE FILM
K833567 · Coloplast A/S · May 1984
ACTIVE LIFE ONE-PIECE STOMA CAP
K840567 · Convatec, A Division of E.R. Squibb & Sons · May 1984
ACTIVE LIFE ONE-PIECE CLOSED-END POUCH
K840568 · Convatec, A Division of E.R. Squibb & Sons · May 1984