510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K162161Substantially Equivalent

Receiver Kit, Trial Kit, Spare Lead Kit, Sterile Revision Kit, Wearable Antenna Assembly Kit and Charger Kit

Stimwave Technologies Incorporated, Fort Lauderdale FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K162161 is the FDA 510(k) clearance record for Receiver Kit, Trial Kit, Spare Lead Kit, Sterile Revision Kit, Wearable Antenna Assembly Kit and Charger Kit, a class II device, cleared for Stimwave Technologies Incorporated on under FDA product code GZB (Stimulator, Spinal-Cord, Implanted (Pain Relief)). FDA records list 8 510(k) clearances for Stimwave Technologies Incorporated, from to . As of , FDA records show no recalls naming K162161.

Clearance record

Decision date
Received
(136 days to decision)
Product code
GZB Stimulator, Spinal-Cord, Implanted (Pain Relief)
Regulation
21 CFR 882.5880
Device class
Class II
Review panel
Neurology
Applicant
Stimwave Technologies Incorporated 901 E Las Olas Blvd., Suite 201, Fort Lauderdale FL
510(k) summary
Summary PDF
Third party review
No

Clearances, product code GZB

Trailing 12 months

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

FDA records show no clearances under product code GZB in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code GZB, 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