Cleared Traditional

K933770 - FORCEPS, ENT INSTR, ENT MANUAL SURG RETRACT/ALL TYPE (FDA 510(k) Clearance)

Class I Ear, Nose, Throat device.

K933770 · Mahe-Medizintechnik · Ear, Nose, Throat device
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Mar 1994
Decision
237d
Days
Class 1
Risk

K933770 is an FDA 510(k) clearance for the FORCEPS, ENT INSTR, ENT MANUAL SURG RETRACT/ALL TYPE. Classified as Instrument, Ent Manual Surgical (product code LRC), Class I - General Controls.

Submitted by Mahe-Medizintechnik (Nashville, US). The FDA issued a Cleared decision on March 23, 1994 after a review of 237 days - an extended review cycle.

This device falls under the Ear, Nose, Throat FDA review panel, regulated under 21 CFR 874.4420 - the FDA ear, nose and throat 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Ear, Nose, Throat review framework, consistent with the majority of Class II 510(k) submissions.

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Submission Details

510(k) Number K933770 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 29, 1993
Decision Date March 23, 1994
Days to Decision 237 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
148d slower than avg
Panel avg: 89d · This submission: 237d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LRC Instrument, Ent Manual Surgical
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 874.4420
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.