Cleared Traditional

K991208 - ENDOSCOPIC FIBEROPTIC CABLE

K991208 is an FDA 510(k) clearance for ENDOSCOPIC FIBEROPTIC CABLE, manufactured by Isolux America. The device is a Class 2 General & Plastic Surgery device with product code HBI cleared through the Traditional 510(k) pathway after a 75-day FDA review.

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

K991208 is an FDA 510(k) clearance for the ENDOSCOPIC FIBEROPTIC CABLE. Classified as Illuminator, Fiberoptic, Surgical Field (product code HBI), Class II - Special Controls.

Submitted by Isolux America (Naples, US). The FDA issued a Cleared decision on June 23, 1999 after a review of 75 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K991208

510(k) Number K991208 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
40d faster than avg
Panel avg: 115d · This submission: 75d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HBI Device Classification - Class 2, Special Controls

Product Code HBI Illuminator, Fiberoptic, Surgical Field
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 - HBI Illuminator, Fiberoptic, Surgical Field

All 26
Devices cleared under the same product code (HBI) and FDA review panel - the closest regulatory comparables to K991208.
LIGHT GUIDE CABLE
K111342 · Schott North America · Nov 2011
1125 XSB XENON FIBER-OPTIC LIGHT SOURCE
K052979 · Isolux, LLC · Oct 2005
ENDOSCOPIC FIBEROPTIC CABLE
K021931 · Gulf Medical Fiberoptics · Sep 2002
LIGHTSOURCE OR ILLUMINATOR MODEL I-100
K983277 · Cuda Products Co. · Dec 1998
LUMINOUS 150 FIBEROPTIC ILLUMINATOR
K933593 · Progressive Dynamics, Inc. · Oct 1993
S1500 XENON LIGHT SOURCE
K922837 · Endomedix · Nov 1992
K991208 · ENDOSCOPIC FIBEROPTIC CABLE
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