Cleared Traditional

K022384 - XENON FIBEROPTIC LIGHT SOURCE, MODEL 1300 XSBP

K022384 is an FDA 510(k) clearance for XENON FIBEROPTIC LIGHT SOURCE, manufactured by Isolux America. The device is a Class 2 Obstetrics & Gynecology device with product code HET cleared through the Traditional 510(k) pathway after a 88-day FDA review.

K022384 · Isolux America · Obstetrics & Gynecology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2002
Decision
88d
Days
Class 2
Risk

K022384 is an FDA 510(k) clearance for the XENON FIBEROPTIC LIGHT SOURCE, MODEL 1300 XSBP. Classified as Laparoscope, Gynecologic (and Accessories) (product code HET), Class II - Special Controls.

Submitted by Isolux America (Naples, US). The FDA issued a Cleared decision on October 18, 2002 after a review of 88 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.

FDA 510(k) Submission Details - K022384

510(k) Number K022384 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 22, 2002
Decision Date October 18, 2002
Days to Decision 88 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
73d faster than avg
Panel avg: 161d · This submission: 88d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HET Device Classification - Class 2, Special Controls

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 325
Devices cleared under the same product code (HET) and FDA review panel - the closest regulatory comparables to K022384.
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K022748 · Medical Device Services · Oct 2002
VASOVIEW 5 HARVESTING CANNULA
K020143 · Guidant Corporation, Cardiac Surgery · Feb 2002
GYNECOLOGICAL LAPAROSCOPES
K003805 · Global Endoscopy, Inc. · Jul 2001
K022384 · XENON FIBEROPTIC LIGHT SOURCE, MODEL 1300 XSBP
Download PDF FDA Summary Isolux America