Cleared Traditional

K811239 - SUR-FIT DISPOSABLE CONVEX INSERT

K811239 is the FDA 510(k) clearance for SUR-FIT DISPOSABLE CONVEX INSERT by E. R. Squibb & Sons, Inc.. It is a Class 1 Gastroenterology & Urology device (product code EXB) cleared through the Traditional 510(k) pathway after a 36-day FDA review.

K811239 · E. R. Squibb & Sons, Inc. · Gastroenterology & Urology device
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Jun 1981
Decision
36d
Days
Class 1
Risk

K811239 is an FDA 510(k) clearance for the SUR-FIT DISPOSABLE CONVEX INSERT. Classified as Collector, Ostomy (product code EXB), Class I - General Controls.

Submitted by E. R. Squibb & Sons, Inc. (New York, US). The FDA issued a Cleared decision on June 9, 1981 after a review of 36 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 E. R. Squibb & Sons, Inc. devices

Submission Details

510(k) Number K811239 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 04, 1981
Decision Date June 09, 1981
Days to Decision 36 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
94d faster than avg
Panel avg: 130d · This submission: 36d
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 K811239.
TWO PIECE OSTOMY SYSTEM
K813269 · Hollister, Inc. · Dec 1981
WOUND DRAINAGE MANAGEMENT SYSTEMS
K813080 · Howmedica Corp. · Nov 1981
SUR-FIT LOOP OSTOMY O.R. SET
K811240 · E. R. Squibb & Sons, Inc. · Jun 1981
FORMULATION CHANGE IN UNITED SKIN BARR
K810726 · Howmedica Corp. · Jun 1981
SUR-FIT DISPOSABLE FANGE CAP
K811163 · E. R. Squibb & Sons, Inc. · May 1981
DRAINING-WOUND MGMT. SYSTEM
K810812 · Johnson & Johnson Professionals, Inc. · Apr 1981