510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K853822Substantially Equivalent

Amoena Breast Forms

MEDLINE INDUSTRIES, LP - Northfield, Marietta GA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K853822 is the FDA 510(k) clearance record for AMOENA BREAST FORMS, a class I device, cleared for Coloplast Corp. on under FDA product code GBI (Material, External Aesthetic Restoration, 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 K853822.

Clearance record

Decision date
Received
(17 days to decision)
Product code
GBI Material, External Aesthetic Restoration, Used With Adhesive
Regulation
21 CFR 878.3800
Device class
Class I
Review panel
General, Plastic Surgery
Applicant
Coloplast Corp. 2150 New Market Pkwy.,, Marietta GA
Third party review
No

Clearances, product code GBI

Trailing 12 months

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

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