510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K062540Substantially Equivalent

Nasopore Ear, Models Nd04, Nd05

Polyganics B.V., Groningen, NL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K062540 is the FDA 510(k) clearance record for NASOPORE EAR, MODELS ND04, ND05, a class I device, cleared for Polyganics B.V., on under FDA product code KCN (Ear Wick). FDA records list 9 510(k) clearances for Polyganics B.V.,, from to . As of , FDA records show no recalls naming K062540.

Clearance record

Decision date
Received
(49 days to decision)
Product code
KCN Ear Wick
Regulation
21 CFR 874.5220
Device class
Class I
Review panel
Ear, Nose, Throat
Applicant
Polyganics B.V., L.J. Zielstraweg 1, Groningen, NL
510(k) summary
Summary PDF
Third party review
No

Clearances, product code KCN

Trailing 12 months

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

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