510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K802016Substantially Equivalent

Eye Applicators Cat.#980-983

Pollak (Intl.).ltd, Walker MI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K802016 is the FDA 510(k) clearance record for EYE APPLICATORS CAT.#980-983, a class I device, cleared for Pollak (Intl.), Ltd. on under FDA product code KXF (Applicator, Absorbent Tipped, Non-Sterile). FDA records list 31 510(k) clearances for Pollak (Intl.), Ltd., from to . As of , FDA records show no recalls naming K802016.

Clearance record

Decision date
Received
(27 days to decision)
Product code
KXF Applicator, Absorbent Tipped, Non-Sterile
Regulation
21 CFR 880.6025
Device class
Class I
Review panel
General Hospital
Applicant
Pollak (Intl.), Ltd. 4221 Richmond Rd., NW, Walker MI
Third party review
No

Clearances, product code KXF

Trailing 12 months

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

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