510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K983385Substantially Equivalent

Hutchison Inflatable Silicone Tissue Expanders

Hutchison Intl., Inc., Bethesda MD / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K983385 is the FDA 510(k) clearance record for HUTCHISON INFLATABLE SILICONE TISSUE EXPANDERS, cleared for Hutchison Intl., Inc. on under FDA product code LCJ (Tissue Expander And Accessories). FDA records list one 510(k) clearance for Hutchison Intl., Inc. As of , FDA records show no recalls naming K983385.

Clearance record

Decision date
Received
(171 days to decision)
Product code
LCJ Tissue Expander And Accessories
Device class
Unclassified
Review panel
Unknown
Applicant
Hutchison Intl., Inc. 7475 Wisconsin Ave.,, Bethesda MD
510(k) summary
Summary
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