Cleared Traditional

K942063 - DISPOSABLE NASAL SCISSOR

K942063 is an FDA 510(k) clearance for DISPOSABLE NASAL SCISSOR, manufactured by United States Surgical, A Division of Tyco Healthc. The device is a Class 1 Ear, Nose, Throat device with product code LRC cleared through the Traditional 510(k) pathway after a 40-day FDA review.

K942063 · United States Surgical, A Division of Tyco Healthc · Ear, Nose, Throat device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1994
Decision
40d
Days
Class 1
Risk

K942063 is an FDA 510(k) clearance for the DISPOSABLE NASAL SCISSOR. Classified as Instrument, Ent Manual Surgical (product code LRC), Class I - General Controls.

Submitted by United States Surgical, A Division of Tyco Healthc (Norwalk, US). The FDA issued a Cleared decision on June 8, 1994 after a review of 40 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 United States Surgical, A Division of Tyco Healthc devices

FDA 510(k) Submission Details - K942063

510(k) Number K942063 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 29, 1994
Decision Date June 08, 1994
Days to Decision 40 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
50d faster than avg
Panel avg: 90d · This submission: 40d
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 62
Devices cleared under the same product code (LRC) and FDA review panel - the closest regulatory comparables to K942063.
FAST TRACT TRANSTRACHEAL PROCEDURE KIT
K970018 · L.W. Ward and Assoc., Inc. · Mar 1997
EXMOOR SINGLE USE MYRINGOTOMES
K942745 · Exmoor Plastics , Ltd. · Sep 1994
SUCKER ENDS (ZOELLNER)
K942746 · Exmoor Plastics , Ltd. · Aug 1994
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