Cleared Traditional

K911756 - POSTERIOR NASAL EPISTAXIS INSTRUMENTS (FDA 510(k) Clearance)

Class I Dental device.

K911756 · Richard Wolf Medical Instruments Corp. · Dental device
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Oct 1991
Decision
189d
Days
Class 1
Risk

K911756 is an FDA 510(k) clearance for the POSTERIOR NASAL EPISTAXIS INSTRUMENTS. Classified as Unit, Syringe, Air And/or Water (product code ECB), Class I - General Controls.

Submitted by Richard Wolf Medical Instruments Corp. (Rosemont, US). The FDA issued a Cleared decision on October 24, 1991 after a review of 189 days - an extended review cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.4565 - the FDA dental device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

View all Richard Wolf Medical Instruments Corp. devices

Submission Details

510(k) Number K911756 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 18, 1991
Decision Date October 24, 1991
Days to Decision 189 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
62d slower than avg
Panel avg: 127d · This submission: 189d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code ECB Unit, Syringe, Air And/or Water
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.4565
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.