510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K010202Substantially Equivalent

Owl Radiofrequency System, Model Urf-2A, and Associate Radiofrequency Lesion Probes

Leslie W. Organ, Charleston SC / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K010202 is the FDA 510(k) clearance record for OWL RADIOFREQUENCY SYSTEM, MODEL URF-2A, AND ASSOCIATE RADIOFREQUENCY LESION PROBES, a class II device, cleared for Leslie W. Organ on under FDA product code GXD (Generator, Lesion, Radiofrequency). FDA records list one 510(k) clearance for Leslie W. Organ. As of , FDA records show no recalls naming K010202.

Clearance record

Decision date
Received
(282 days to decision)
Product code
GXD Generator, Lesion, Radiofrequency
Regulation
21 CFR 882.4400
Device class
Class II
Review panel
Neurology
Applicant
Leslie W. Organ 1837 Kempton Rd., Charleston SC
510(k) summary
Summary
Third party review
No

Clearances, product code GXD

Trailing 12 months

FDA records hold no clearances under product code GXD in the trailing twelve months.

FDA records show no clearances under product code GXD in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code GXD, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260