510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K965187Substantially Equivalent

Spectrum II, Spectrum Plus, and Spectrum Max-Sd

Sparta Surgical Corp., Great Neck, NY / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K965187 is the FDA 510(k) clearance record for SPECTRUM II, SPECTRUM PLUS, AND SPECTRUM MAX-SD, a class II device, cleared for Sparta Surgical Corp. on under FDA product code GZJ (Stimulator, Nerve, Transcutaneous, For Pain Relief). FDA records list 7 510(k) clearances for Sparta Surgical Corp., from to . As of , FDA records show no recalls naming K965187.

Clearance record

Decision date
Received
(220 days to decision)
Product code
GZJ Stimulator, Nerve, Transcutaneous, For Pain Relief
Regulation
21 CFR 882.5890
Device class
Class II
Review panel
Neurology
Applicant
Sparta Surgical Corp. 55 Northern Blvd., Suite 410, Great Neck, NY
510(k) summary
Statement
Third party review
No

Clearances, product code GZJ

Trailing 12 months
2 clearances under product code GZJ in the twelve months to October 2026, January 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code GZJ, trailing twelve months
MonthClearances
November 20250
December 20250
January 20261
February 20260
March 20260
April 20260
May 20261
June 20260
July 20260
August 20260
September 20260
October 20260