Cleared Traditional

K821336 - TRANSENDOSCOPIC INJECTION CATHETER TEI

K821336 is the FDA 510(k) clearance for TRANSENDOSCOPIC INJECTION CATHETER TEI by Sounson Research Co., Inc.. It is a Class 2 Gastroenterology & Urology device (product code KNY) cleared through the Traditional 510(k) pathway after a 16-day FDA review.

K821336 · Sounson Research Co., Inc. · Gastroenterology & Urology device
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May 1982
Decision
16d
Days
Class 2
Risk

K821336 is an FDA 510(k) clearance for the TRANSENDOSCOPIC INJECTION CATHETER TEI. Classified as Accessories, Catheter, G-u (product code KNY), Class II - Special Controls.

Submitted by Sounson Research Co., Inc. (Mchenry, US). The FDA issued a Cleared decision on May 21, 1982 after a review of 16 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5130 - 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 Sounson Research Co., Inc. devices

Submission Details

510(k) Number K821336 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 05, 1982
Decision Date May 21, 1982
Days to Decision 16 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
114d faster than avg
Panel avg: 130d · This submission: 16d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KNY Accessories, Catheter, G-u
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5130
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 - KNY Accessories, Catheter, G-u

All 23
Devices cleared under the same product code (KNY) and FDA review panel - the closest regulatory comparables to K821336.
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