Cleared Traditional

K800962 - M.R. ASSOC. WASHING TUBE/MEASURING TUBE

K800962 is the FDA 510(k) clearance for M.R. ASSOC. WASHING TUBE/MEASURING TUBE by Mr Associates, Inc.. It is a Class 2 Gastroenterology & Urology device (product code ODC) cleared through the Traditional 510(k) pathway after a 15-day FDA review.

K800962 · Mr Associates, Inc. · Gastroenterology & Urology device
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May 1980
Decision
15d
Days
Class 2
Risk

K800962 is an FDA 510(k) clearance for the M.R. ASSOC. WASHING TUBE/MEASURING TUBE. Classified as Endoscope Channel Accessory (product code ODC), Class II - Special Controls.

Submitted by Mr Associates, Inc. (Mchenry, US). The FDA issued a Cleared decision on May 8, 1980 after a review of 15 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.1500 - 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 Mr Associates, Inc. devices

Submission Details

510(k) Number K800962 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 23, 1980
Decision Date May 08, 1980
Days to Decision 15 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
115d faster than avg
Panel avg: 130d · This submission: 15d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code ODC Endoscope Channel Accessory
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1500
Definition To Give The Endoscope Channel Additional Or Improved Functionality.
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 - ODC Endoscope Channel Accessory

All 50
Devices cleared under the same product code (ODC) and FDA review panel - the closest regulatory comparables to K800962.
CONCENTRIC BALLOON GOOGLE
K112698 · United States Endoscopy Group, Inc. · May 2012
ETHICON ENDO SURGERY SHEATH AND ARTICULATING ACCESSORY CHANNEL - GASTROSCOPE, MODEL IN0431
K073484 · Ethicon Endo-Surgery, Inc. · Mar 2008
RAPID EXCHANGE BIOPSY CAP AND LOCKING DEVICE #4526 & 4527
K010610 · Boston Scientific Corp · Mar 2001