510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K172644Substantially Equivalent

Sandshark Injectable Anchor Kit, Injectroducer Handle, Loading Rod with Anchor, Loading Base

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

K172644 is the FDA 510(k) clearance record for Sandshark Injectable Anchor Kit, Injectroducer Handle, Loading Rod with Anchor, Loading Base, 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 K172644.

Clearance record

Decision date
Received
(63 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 1310 Park Central Blvd. S, Pompano Beach 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