510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K101592Substantially Equivalent

Erase Hand- Held Controller; Erase Single Use Electric Catridge System

Cheng Medical, Corporation, Saratoga CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K101592 is the FDA 510(k) clearance record for ERASE HAND- HELD CONTROLLER; ERASE SINGLE USE ELECTRIC CATRIDGE SYSTEM, a class II device, cleared for Cheng Medical, Corporation on under FDA product code GXD (Generator, Lesion, Radiofrequency). FDA records list one 510(k) clearance for Cheng Medical, Corporation. As of , FDA records show no recalls naming K101592.

Clearance record

Decision date
Received
(486 days to decision)
Product code
GXD Generator, Lesion, Radiofrequency
Regulation
21 CFR 882.4400
Device class
Class II
Review panel
Neurology
Applicant
Cheng Medical, Corporation 12945 Saratoga Ave., Saratoga CA
510(k) summary
Summary PDF
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