510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K083087Substantially Equivalent

Ecocel

Polichem SA, Rockville MD / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K083087 is the FDA 510(k) clearance record for ECOCEL, a class I device, cleared for Polichem S.A on under FDA product code KMF (Bandage, Liquid). FDA records list 3 510(k) clearances for Polichem S.A, from to . As of , FDA records show no recalls naming K083087.

Clearance record

Decision date
Received
(295 days to decision)
Product code
KMF Bandage, Liquid
Regulation
21 CFR 880.5090
Device class
Class I
Review panel
General Hospital
Applicant
Polichem S.A 7361 Calhoun Pl., Suite 500, Rockville MD
510(k) summary
Summary PDF
Third party review
No

Clearances, product code KMF

Trailing 12 months

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

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