Cleared Traditional

K941661 - GM OPTI*CAM CAMER WITH DENTAL FIBER OPT...

K941661 is an FDA 510(k) clearance for GM OPTI*CAM CAMER WITH DENTAL FIBER OPT..., manufactured by Gm Engineering, Inc.. The device is a Class 1 Ear, Nose, Throat device with product code EQH cleared through the Traditional 510(k) pathway after a 140-day FDA review.

K941661 · Gm Engineering, Inc. · Ear, Nose, Throat device
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Optimized for regulatory review, auditing and printing
Aug 1994
Decision
140d
Days
Class 1
Risk

K941661 is an FDA 510(k) clearance for the GM OPTI*CAM CAMER WITH DENTAL FIBER OPTIC LIGHT. Classified as Source, Carrier, Fiberoptic Light (product code EQH), Class I - General Controls.

Submitted by Gm Engineering, Inc. (La Verne, US). The FDA issued a Cleared decision on August 23, 1994 after a review of 140 days - within the typical 510(k) review window.

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 Gm Engineering, Inc. devices

FDA 510(k) Submission Details - K941661

510(k) Number K941661 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 05, 1994
Decision Date August 23, 1994
Days to Decision 140 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
51d slower than avg
Panel avg: 89d · This submission: 140d
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 25
Devices cleared under the same product code (EQH) and FDA review panel - the closest regulatory comparables to K941661.
JED-LIGHT FIBEROPTIC LIGHT SOURCE
K954184 · Jedmed Instrument Co. · Nov 1995
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
FIBEROPTIC LIGHT SOURCE, FOI-1A
K896384 · Jedmed Instrument Co. · Jan 1990