Cleared Traditional

K904616 - STORZ ULTRA-SOURCE HIGH OUTPUT ILLUMINATOR

K904616 is an FDA 510(k) clearance for STORZ ULTRA-SOURCE HIGH OUTPUT ILLUMINATOR, manufactured by Storz Instrument Co.. The device is a Class 2 General & Plastic Surgery device with product code HBI cleared through the Traditional 510(k) pathway after a 190-day FDA review.

K904616 · Storz Instrument Co. · General & Plastic Surgery device
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Apr 1991
Decision
190d
Days
Class 2
Risk

K904616 is an FDA 510(k) clearance for the STORZ ULTRA-SOURCE HIGH OUTPUT ILLUMINATOR. 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 April 19, 1991 after a review of 190 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Storz Instrument Co. devices

FDA 510(k) Submission Details - K904616

510(k) Number K904616 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 11, 1990
Decision Date April 19, 1991
Days to Decision 190 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
75d slower than avg
Panel avg: 115d · This submission: 190d
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 9
Devices cleared under the same product code (HBI) and FDA review panel - the closest regulatory comparables to K904616.
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K890398 · Advanced Surgical Products, Inc. · Feb 1989
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