Cleared Traditional

K800397 - ELLIK BLADDER EVACUATOR

K800397 is an FDA 510(k) clearance for ELLIK BLADDER EVACUATOR, manufactured by Sage Products, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code KQT cleared through the Traditional 510(k) pathway after a 13-day FDA review.

K800397 · Sage Products, Inc. · Gastroenterology & Urology device
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Mar 1980
Decision
13d
Days
Class 2
Risk

K800397 is an FDA 510(k) clearance for the ELLIK BLADDER EVACUATOR. Classified as Evacuator, Gastro-urology (product code KQT), Class II - Special Controls.

Submitted by Sage Products, Inc. (Mchenry, US). The FDA issued a Cleared decision on March 10, 1980 after a review of 13 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.4370 - 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 Sage Products, Inc. devices

FDA 510(k) Submission Details - K800397

510(k) Number K800397 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 26, 1980
Decision Date March 10, 1980
Days to Decision 13 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
118d faster than avg
Panel avg: 131d · This submission: 13d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KQT Device Classification - Class 2, Special Controls

Product Code KQT Evacuator, Gastro-urology
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.4370
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 - KQT Evacuator, Gastro-urology

All 9
Devices cleared under the same product code (KQT) and FDA review panel - the closest regulatory comparables to K800397.
ROSS-EMERSON PUMP, MODEL 55-R
K811779 · J. H. Emerson Co. · Jul 1981
CATHETER IRRIGATION SYRINGES, #3100,3110
K801781 · The Healthcare Group Laboratories, Inc. · Aug 1980
GENERAL PURPOSE IRRIGATING/ASPIR SYR.
K801782 · The Healthcare Group Laboratories, Inc. · Aug 1980
ELLIK EVACUATOR
K791306 · Davol, Inc. · Aug 1979