Cleared Traditional

K841003 - PROBES, VARIOUS (FDA 510(k) Clearance)

Class I Gastroenterology & Urology device.

K841003 · Premier Dental Products Co. · Gastroenterology & Urology device
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Mar 1984
Decision
11d
Days
Class 1
Risk

K841003 is an FDA 510(k) clearance for the PROBES, VARIOUS. Classified as Surgical Instruments, G-u, Manual (and Accessories) (product code KOA), Class I - General Controls.

Submitted by Premier Dental Products Co. (Norristown, US). The FDA issued a Cleared decision on March 20, 1984 after a review of 11 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.4730 - 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 Premier Dental Products Co. devices

Submission Details

510(k) Number K841003 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 09, 1984
Decision Date March 20, 1984
Days to Decision 11 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
119d faster than avg
Panel avg: 130d · This submission: 11d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code KOA Surgical Instruments, G-u, Manual (and Accessories)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 876.4730
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.