Cleared Traditional

K934911 - SAPHIRE PLUS SURGICAL MIRROR

K934911 is an FDA 510(k) clearance for SAPHIRE PLUS SURGICAL MIRROR, manufactured by San Diego Swiss Machining, Inc.. The device is a Class 1 Ear, Nose, Throat device with product code EQH cleared through the Traditional 510(k) pathway after a 250-day FDA review.

K934911 · San Diego Swiss Machining, Inc. · Ear, Nose, Throat device
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Jun 1994
Decision
250d
Days
Class 1
Risk

K934911 is an FDA 510(k) clearance for the SAPHIRE PLUS SURGICAL MIRROR. Classified as Source, Carrier, Fiberoptic Light (product code EQH), Class I - General Controls.

Submitted by San Diego Swiss Machining, Inc. (San Diego, US). The FDA issued a Cleared decision on June 21, 1994 after a review of 250 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 San Diego Swiss Machining, Inc. devices

FDA 510(k) Submission Details - K934911

510(k) Number K934911 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 14, 1993
Decision Date June 21, 1994
Days to Decision 250 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
161d slower than avg
Panel avg: 89d · This submission: 250d
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 K934911.
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