Cleared Traditional

K854587 - STORZ MVS DISPOSABLE FIBEROPTIC LIGHTPIPE

K854587 is the FDA 510(k) clearance for STORZ MVS DISPOSABLE FIBEROPTIC LIGHTPIPE by Storz Instrument Co.. It is a Class 2 General & Plastic Surgery device (product code HBI) cleared through the Traditional 510(k) pathway after a 78-day FDA review.

K854587 · Storz Instrument Co. · General & Plastic Surgery device
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Feb 1986
Decision
78d
Days
Class 2
Risk

K854587 is an FDA 510(k) clearance for the STORZ MVS DISPOSABLE FIBEROPTIC LIGHTPIPE. Classified as Illuminator, Fiberoptic, Surgical Field (product code HBI), Class II - Special Controls.

Submitted by Storz Instrument Co. (St. Louis, US). The FDA issued a Cleared decision on February 4, 1986 after a review of 78 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.

View all Storz Instrument Co. devices

Submission Details

510(k) Number K854587 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 18, 1985
Decision Date February 04, 1986
Days to Decision 78 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
37d faster than avg
Panel avg: 115d · This submission: 78d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 9
Devices cleared under the same product code (HBI) and FDA review panel - the closest regulatory comparables to K854587.
FIBEROPTIC BLUNT INTEGRAL PICK LIGHTPIPE
K883856 · Advanced Surgical Products, Inc. · Sep 1988
FIBEROPTIC WIRE PICK LIGHTPIPE
K883857 · Advanced Surgical Products, Inc. · Sep 1988
FIBEROPTIC SHARP INTEGRAL PICK LIGHTPIPE
K883858 · Advanced Surgical Products, Inc. · Sep 1988
FIBER OPTIC ADAPTERS#60-0891
K810299 · Aspen Laboratories, Inc. · Feb 1981
FIBER OPTIC ADAPTERS#60-0893
K810300 · Aspen Laboratories, Inc. · Feb 1981