Cleared Traditional

ENDOSCOPIC FIBEROPTIC CABLE

K991208 · Isolux America · General & Plastic Surgery
Jun 1999
Decision
75d
Days
Class 2
Risk

About This 510(k) Submission

K991208 is an FDA 510(k) clearance for the ENDOSCOPIC FIBEROPTIC CABLE, a Illuminator, Fiberoptic, Surgical Field (Class II — Special Controls, product code HBI), submitted by Isolux America (Naples, US). The FDA issued a Cleared decision on June 23, 1999, 75 days after receiving the submission on April 9, 1999. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4580.

Submission Details

510(k) Number K991208 FDA.gov
FDA Decision Cleared SESE
Date Received April 09, 1999
Decision Date June 23, 1999
Days to Decision 75 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement

Device Classification

Product Code HBI — Illuminator, Fiberoptic, Surgical Field
Device Class Class II — Special Controls
CFR Regulation 21 CFR 878.4580