Cleared Traditional

K923227 - THROAT-A-SCOPE

K923227 is an FDA 510(k) clearance for THROAT-A-SCOPE, manufactured by Truphatek, Ltd.. The device is a Class 1 Ear, Nose, Throat device with product code EQH cleared through the Traditional 510(k) pathway after a 156-day FDA review.

K923227 · Truphatek, Ltd. · Ear, Nose, Throat device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1992
Decision
156d
Days
Class 1
Risk

K923227 is an FDA 510(k) clearance for the THROAT-A-SCOPE. Classified as Source, Carrier, Fiberoptic Light (product code EQH), Class I - General Controls.

Submitted by Truphatek, Ltd. (Netanya, IL). The FDA issued a Cleared decision on December 4, 1992 after a review of 156 days - an extended review cycle.

This device falls under the Ear, Nose, Throat FDA review panel, regulated under 21 CFR 874.4350 - 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.

View all Truphatek, Ltd. devices

FDA 510(k) Submission Details - K923227

510(k) Number K923227 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 01, 1992
Decision Date December 04, 1992
Days to Decision 156 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
66d slower than avg
Panel avg: 90d · This submission: 156d
Pathway characteristics
Predicate-based equivalence.

EQH Device Classification - Class 1, General Controls

Product Code EQH Source, Carrier, Fiberoptic Light
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 874.4350
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 - EQH Source, Carrier, Fiberoptic Light

All 26
Devices cleared under the same product code (EQH) and FDA review panel - the closest regulatory comparables to K923227.
JED-LIGHT FIBEROPTIC LIGHT SOURCE
K954184 · Jedmed Instrument Co. · Nov 1995
MID LABS TWIN ILLUMINATOR
K932131 · Medical Instrument Development Laboratories, Inc. · Apr 1994
ASPIRATING ENDO OCULAR PROBE
K930123 · Surgical Technologies, Inc. · Feb 1994
LX 150 LIGHT SOURCE
K922095 · Welch Allyn, Inc. · Jul 1992
ASPIRATING ENDO OCULAR PROBE
K914247 · Surgical Technologies, Inc. · Dec 1991
KAPS 90 DEGREE FIBEROPTIC ADAPTOR
K912885 · Jedmed Instrument Co. · Aug 1991