510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K974480Substantially Equivalent

Silimed Calf Implant

Silimed, LLC, Crofton MD / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K974480 is the FDA 510(k) clearance record for SILIMED CALF IMPLANT, a class II device, cleared for Silimed, LLC on under FDA product code MIB (Elastomer, Silicone Block). FDA records list 10 510(k) clearances for Silimed, LLC, from to . As of , FDA records show no recalls naming K974480.

Clearance record

Decision date
Received
(90 days to decision)
Product code
MIB Elastomer, Silicone Block
Regulation
21 CFR 874.3620
Device class
Class II
Review panel
Ear, Nose, Throat
Applicant
Silimed, LLC P.O. Box 4341, Crofton MD
510(k) summary
Statement
Third party review
No

Clearances, product code MIB

Trailing 12 months

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

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