510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K904085Substantially Equivalent

Ella Breast Form

MEDLINE INDUSTRIES, LP - Northfield, Fort Woth TX / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K904085 is the FDA 510(k) clearance record for ELLA BREAST FORM, a class I device, cleared for Coloplast A/S on under FDA product code KCZ (Prosthesis, Breast, External, Used With Adhesive). FDA records list 414 510(k) clearances for MEDLINE INDUSTRIES, LP - Northfield, from to . As of , FDA records show no recalls naming K904085.

Clearance record

Decision date
Received
(56 days to decision)
Product code
KCZ Prosthesis, Breast, External, Used With Adhesive
Regulation
21 CFR 878.3800
Device class
Class I
Review panel
General, Plastic Surgery
Applicant
Coloplast A/S C/O Richard Hamer Assoc.Inc., Fort Woth TX
Third party review
No

Clearances, product code KCZ

Trailing 12 months

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

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