Cleared Traditional

K811160 - SUR-FIT IRRIGATION SLEEVE

K811160 is the FDA 510(k) clearance for SUR-FIT IRRIGATION SLEEVE by E. R. Squibb & Sons, Inc.. It is a Class 2 Gastroenterology & Urology device (product code EXD) cleared through the Traditional 510(k) pathway after a 35-day FDA review.

K811160 · E. R. Squibb & Sons, Inc. · Gastroenterology & Urology device
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Jun 1981
Decision
35d
Days
Class 2
Risk

K811160 is an FDA 510(k) clearance for the SUR-FIT IRRIGATION SLEEVE. Classified as Irrigator, Ostomy (product code EXD), Class II - Special Controls.

Submitted by E. R. Squibb & Sons, Inc. (New York, US). The FDA issued a Cleared decision on June 2, 1981 after a review of 35 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5895 - 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 K811160 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 28, 1981
Decision Date June 02, 1981
Days to Decision 35 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
95d faster than avg
Panel avg: 130d · This submission: 35d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code EXD Irrigator, Ostomy
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5895
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Gastroenterology & Urology devices follow this clearance model.

Regulatory Peers - EXD Irrigator, Ostomy

All 7
Devices cleared under the same product code (EXD) and FDA review panel - the closest regulatory comparables to K811160.
IRRIGATION SYSTEM
K840268 · Coloplast A/S · Apr 1984
VISI-FLOW IRRIGATOR
K832299 · Convatec, A Division of E.R. Squibb & Sons · Aug 1983
UNI-TIP COLOSTOMY IRRIGATION CONE
K823274 · Howmedica Corp. · Dec 1982
TUBE, GASTRO-ENTEROSTOMY
K760810 · Sherwood Medical Industries · Feb 1977
SUPER X ADJUSTRETTE
K770251 · Qualitone · Feb 1977