AMERICAN EDWARDS LABORATORIES FLEXISCOPE

K852759 · American Edwards Laboratories · HRX · Aug 22, 1985 · Orthopedic

Device Facts

Record IDK852759
Device NameAMERICAN EDWARDS LABORATORIES FLEXISCOPE
ApplicantAmerican Edwards Laboratories
Product CodeHRX · Orthopedic
Decision DateAug 22, 1985
DecisionSESE
Submission TypeTraditional
Regulation21 CFR 888.1100
Device ClassClass 2

Regulatory Classification

Identification

An arthroscope is an electrically powered endoscope intended to make visible the interior of a joint. The arthroscope and accessories also is intended to perform surgery within a joint.

Innolitics

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