Cleared Traditional

K930292 - HOUSE-BELLUCCI ALLIGATOR SCISSORS

K930292 is an FDA 510(k) clearance for HOUSE-BELLUCCI ALLIGATOR SCISSORS, manufactured by Thomasville Medical Assoc.. The device is a Class 1 Ear, Nose, Throat device with product code LRC cleared through the Traditional 510(k) pathway after a 57-day FDA review.

K930292 · Thomasville Medical Assoc. · Ear, Nose, Throat device
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Mar 1993
Decision
57d
Days
Class 1
Risk

K930292 is an FDA 510(k) clearance for the HOUSE-BELLUCCI ALLIGATOR SCISSORS. Classified as Instrument, Ent Manual Surgical (product code LRC), Class I - General Controls.

Submitted by Thomasville Medical Assoc. (Alpharetta, US). The FDA issued a Cleared decision on March 19, 1993 after a review of 57 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 Thomasville Medical Assoc. devices

FDA 510(k) Submission Details - K930292

510(k) Number K930292 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 21, 1993
Decision Date March 19, 1993
Days to Decision 57 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
32d faster than avg
Panel avg: 89d · This submission: 57d
Pathway characteristics
Predicate-based equivalence.

LRC Device Classification - Class 1, General Controls

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.

Regulatory Peers - LRC Instrument, Ent Manual Surgical

All 54
Devices cleared under the same product code (LRC) and FDA review panel - the closest regulatory comparables to K930292.
DISPOSABLE NASAL RONGEUR
K942064 · United States Surgical, A Division of Tyco Healthc · Jun 1994
DISPOSABLE ENT PUNCH
K942065 · United States Surgical, A Division of Tyco Healthc · Jun 1994
SYMBIOSIS ENT SURGICAL INSTRUMENTS
K931793 · Symbiosis Corp. · Jul 1993
ATMOS MIRROR WARMER
K920988 · Jedmed Instrument Co. · May 1992
'EXMOOR' SINGLE USE SUCTION TUBE
K892504 · Exmoor Plastics , Ltd. · Jun 1989
FLEXIBLE ENDOSCOPE 91-8200(90) AND 91-82100(135)
K884631 · Xomed, Inc. · Mar 1989