510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K894495Substantially Equivalent

Surgitek(r) External Fill Port

Surgitek, Racine WI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K894495 is the FDA 510(k) clearance record for SURGITEK(R) EXTERNAL FILL PORT, cleared for Surgitek on under FDA product code LCJ (Tissue Expander And Accessories). FDA records list 29 510(k) clearances for Surgitek, from to . As of , FDA records show no recalls naming K894495.

Clearance record

Decision date
Received
(182 days to decision)
Product code
LCJ Tissue Expander And Accessories
Device class
Unclassified
Review panel
Unknown
Applicant
Surgitek 3037 Mt. Pleasant St., Racine WI
Third party review
No

Clearances, product code LCJ

Trailing 12 months
1 clearance under product code LCJ in the twelve months to October 2026, January 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code LCJ, trailing twelve months
MonthClearances
November 20250
December 20250
January 20261
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260