Cleared Traditional

K930686 - MIDMARK SURGICAL LIGHTING SYSTEMS

K930686 is an FDA 510(k) clearance for MIDMARK SURGICAL LIGHTING SYSTEMS, manufactured by Midmark Corp.. The device is a Class 2 General & Plastic Surgery device with product code FSQ cleared through the Traditional 510(k) pathway after a 170-day FDA review.

K930686 · Midmark Corp. · General & Plastic Surgery device
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Jul 1993
Decision
170d
Days
Class 2
Risk

K930686 is an FDA 510(k) clearance for the MIDMARK SURGICAL LIGHTING SYSTEMS. Classified as Light, Surgical, Instrument (product code FSQ), Class II - Special Controls.

Submitted by Midmark Corp. (Versailles, US). The FDA issued a Cleared decision on July 30, 1993 after a review of 170 days - an extended review cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4580 - the FDA general and plastic surgery 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 General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K930686

510(k) Number K930686 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 10, 1993
Decision Date July 30, 1993
Days to Decision 170 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
55d slower than avg
Panel avg: 115d · This submission: 170d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FSQ Device Classification - Class 2, Special Controls

Product Code FSQ Light, Surgical, Instrument
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4580
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General & Plastic Surgery devices follow this clearance model.

Regulatory Peers - FSQ Light, Surgical, Instrument

Devices cleared under the same product code (FSQ) and FDA review panel - the closest regulatory comparables to K930686.
LIGHTED INTUBATION STYLET W/REPLACEABLE SHAFT
K932139 · Aaron Medical Industries · Jul 1993
ALM ILLUMINATOR SERIES LIGHT SYSTEM
K922409 · Alm Surgical Equipment, Inc. · Jan 1993
BFW WEHMERLITE IV-A FIBER OPTIC SURG. HEADLIGHT
K921848 · Alm Surgical Equipment, Inc. · Oct 1992
SURG-FLEX 10 LIGHT
K803067 · Medical Products Development, Inc. · Feb 1981
SURG-FLEX 5 SURGICAL LIGHT
K810018 · Medical Products Development, Inc. · Jan 1981
SURG-FLEX 15 SURGICAL LIGHT
K810019 · Medical Products Development, Inc. · Jan 1981
K930686 · MIDMARK SURGICAL LIGHTING SYSTEMS
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