Cleared Traditional

K980166 - LIGHTSOURCE OR ILLUMINATOR

K980166 is the FDA 510(k) clearance for LIGHTSOURCE OR ILLUMINATOR by Cuda Products Co.. It is a Class 2 Obstetrics & Gynecology device (product code HET) cleared through the Traditional 510(k) pathway after a 75-day FDA review.

K980166 · Cuda Products Co. · Obstetrics & Gynecology device
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Apr 1998
Decision
75d
Days
Class 2
Risk

K980166 is an FDA 510(k) clearance for the LIGHTSOURCE OR ILLUMINATOR. Classified as Laparoscope, Gynecologic (and Accessories) (product code HET), Class II - Special Controls.

Submitted by Cuda Products Co. (Jacksonville, US). The FDA issued a Cleared decision on April 1, 1998 after a review of 75 days - a notably fast clearance cycle.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.1720 - the FDA obstetrics and gynecology 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 Cuda Products Co. devices

Submission Details

510(k) Number K980166 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 16, 1998
Decision Date April 01, 1998
Days to Decision 75 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
85d faster than avg
Panel avg: 160d · This submission: 75d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HET Laparoscope, Gynecologic (and Accessories)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.1720
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 Obstetrics & Gynecology devices follow this clearance model.

Regulatory Peers - HET Laparoscope, Gynecologic (and Accessories)

All 151
Devices cleared under the same product code (HET) and FDA review panel - the closest regulatory comparables to K980166.
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CO2 PNEUMO-DISSECTOR
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K962985 · KARL STORZ Endoscopy-America, Inc. · Dec 1997
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K973737 · Richard Wolf Medical Instruments Corp. · Dec 1997