Cleared Traditional

K914585 - GRIESHABER TWO FUNCTION MANIPULATOR

K914585 is an FDA 510(k) clearance for GRIESHABER TWO FUNCTION MANIPULATOR, manufactured by Grieshaber & Co.. The device is a Class 1 Ear, Nose, Throat device with product code EQH cleared through the Traditional 510(k) pathway after a 79-day FDA review.

K914585 · Grieshaber & Co. · Ear, Nose, Throat device
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Jan 1992
Decision
79d
Days
Class 1
Risk

K914585 is an FDA 510(k) clearance for the GRIESHABER TWO FUNCTION MANIPULATOR. Classified as Source, Carrier, Fiberoptic Light (product code EQH), Class I - General Controls.

Submitted by Grieshaber & Co. (Langhorne, US). The FDA issued a Cleared decision on January 3, 1992 after a review of 79 days - a notably fast clearance 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: 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 Grieshaber & Co. devices

FDA 510(k) Submission Details - K914585

510(k) Number K914585 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 16, 1991
Decision Date January 03, 1992
Days to Decision 79 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
11d faster than avg
Panel avg: 90d · This submission: 79d
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 K914585.
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
FIBEROPTIC LIGHT SOURCE, FOI-1A
K896384 · Jedmed Instrument Co. · Jan 1990