Cleared Traditional

MIDMARK SURGICAL LIGHTING SYSTEMS

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

About This 510(k) Submission

K930686 is an FDA 510(k) clearance for the MIDMARK SURGICAL LIGHTING SYSTEMS, a Light, Surgical, Instrument (Class II — Special Controls, product code FSQ), submitted by Midmark Corp. (Versailles, US). The FDA issued a Cleared decision on July 30, 1993, 170 days after receiving the submission on February 10, 1993. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4580.

Submission Details

510(k) Number K930686 FDA.gov
FDA Decision Cleared 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

Device Classification

Product Code FSQ — Light, Surgical, Instrument
Device Class Class II — Special Controls
CFR Regulation 21 CFR 878.4580

Similar Devices — FSQ Light, Surgical, Instrument

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