510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K853767Substantially Equivalent

Flospik

Medelco, Ltd., Stratford CT / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K853767 is the FDA 510(k) clearance record for FLOSPIK, a class I device, cleared for Medelco , Ltd. on under FDA product code JES (Floss, Dental). FDA records list 4 510(k) clearances for Medelco , Ltd., from to . As of , FDA records show no recalls naming K853767.

Clearance record

Decision date
Received
(84 days to decision)
Product code
JES Floss, Dental
Regulation
21 CFR 872.6390
Device class
Class I
Review panel
Dental
Applicant
Medelco , Ltd. 1670 S. Ave., Stratford CT
Third party review
No

Clearances, product code JES

Trailing 12 months

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

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