Cleared Traditional

K863986 - XENON LIGHT SOURCE FOR ENDOSCOPIC PROCEDURES

K863986 is an FDA 510(k) clearance for XENON LIGHT SOURCE FOR ENDOSCOPIC PROCE..., manufactured by American Edwards Laboratories. The device is a Class 2 Orthopedic device with product code HRX cleared through the Traditional 510(k) pathway after a 17-day FDA review.

K863986 · American Edwards Laboratories · Orthopedic device
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Oct 1986
Decision
17d
Days
Class 2
Risk

K863986 is an FDA 510(k) clearance for the XENON LIGHT SOURCE FOR ENDOSCOPIC PROCEDURES. Classified as Arthroscope (product code HRX), Class II - Special Controls.

Submitted by American Edwards Laboratories (Santa Ana, US). The FDA issued a Cleared decision on October 31, 1986 after a review of 17 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.1100 - the FDA orthopedic device regulatory 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 - K863986

510(k) Number K863986 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 14, 1986
Decision Date October 31, 1986
Days to Decision 17 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
105d faster than avg
Panel avg: 122d · This submission: 17d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HRX Device Classification - Class 2, Special Controls

Product Code HRX Arthroscope
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.1100
Definition Validated Reprocessing Instructions And Reprocessing Validation Data For This Device Type Must Be Included In A 510(k) Submission If The Device Is Reusable And Has Specific Design Features (please Refer To Table 2 Of 82 Fr 26807, Available At Https://www.gpo.gov/fdsys/pkg/fr-2017-06-09/pdf/2017-12007.pdf).
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 Orthopedic devices follow this clearance model.

Regulatory Peers - HRX Arthroscope

All 684
Devices cleared under the same product code (HRX) and FDA review panel - the closest regulatory comparables to K863986.
LEG HOLDER
K864476 · American Container Technology, Inc. · Dec 1986
LP ARTHROSCOPIC THIGH HOLDING DEVICE
K864513 · Twin Falls Orthopedic Associates, P.A. · Nov 1986
HALL DUNBAR DRILL GUIDE SYSTEM
K864163 · Hall Surgical, Division of Zimmer, Inc. · Nov 1986
CANCELLOUS SCREW
K862990 · Orthopedic Systems, Inc. · Oct 1986
LIGAMENT WASHER
K862991 · Orthopedic Systems, Inc. · Oct 1986
UNIVERSAL CANNULA SYSTEM
K863590 · Aspen Laboratories, Inc. · Oct 1986
K863986 · XENON LIGHT SOURCE FOR ENDOSCOPIC PROCEDURES
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