510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K220735Substantially Equivalent

Avologi Gel Primer (Model: Av25)

Premier North America, Inc, Fort Lauderdale FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K220735 is the FDA 510(k) clearance record for Avologi Gel Primer (Model: Av25), a class II device, cleared for Premier North America, Inc. on under FDA product code GYB (Media, Electroconductive). FDA records list 6 510(k) clearances for Premier North America, Inc., from to . As of , FDA records show no recalls naming K220735.

Clearance record

Decision date
Received
(550 days to decision)
Product code
GYB Media, Electroconductive
Regulation
21 CFR 882.1275
Device class
Class II
Review panel
Neurology
Applicant
Premier North America, Inc. 3301 SW 42nd St., Fort Lauderdale FL
510(k) summary
Summary PDF
Third party review
No

Clearances, product code GYB

Trailing 12 months

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

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