Cleared Traditional

K791121 - ALLIGATOR FORECPTS, CUPPED FORCEPS

K791121 is an FDA 510(k) clearance for ALLIGATOR FORECPTS, manufactured by Xomed, Inc.. The device is a Class 1 Ear, Nose, Throat device with product code JYR cleared through the Traditional 510(k) pathway after a 12-day FDA review.

K791121 · Xomed, Inc. · Ear, Nose, Throat device
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Jun 1979
Decision
12d
Days
Class 1
Risk

K791121 is an FDA 510(k) clearance for the ALLIGATOR FORECPTS, CUPPED FORCEPS. Classified as Nipper, Malleus (product code JYR), Class I - General Controls.

Submitted by Xomed, Inc. (Arnold, US). The FDA issued a Cleared decision on June 27, 1979 after a review of 12 days - a notably fast clearance 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: 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 Xomed, Inc. devices

FDA 510(k) Submission Details - K791121

510(k) Number K791121 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 15, 1979
Decision Date June 27, 1979
Days to Decision 12 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
78d faster than avg
Panel avg: 90d · This submission: 12d
Pathway characteristics
Predicate-based equivalence.

JYR Device Classification - Class 1, General Controls

Product Code JYR Nipper, Malleus
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.