510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K842765Substantially Equivalent

Silimed Breast Form

Sil-Med Corp., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K842765 is the FDA 510(k) clearance record for SILIMED BREAST FORM, a class I device, cleared for Sil-Med Corp. on under FDA product code GBI (Material, External Aesthetic Restoration, Used With Adhesive). FDA records list 29 510(k) clearances for Sil-Med Corp., from to . As of , FDA records show no recalls naming K842765.

Clearance record

Decision date
Received
(32 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
Sil-Med Corp. 803 N. Front St. Suite 3, Mchenry IL
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