510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K080158Substantially Equivalent

Lb Medical Inflatable Tissue Elevator/expander System

Lb Medical LLC, Alexandria VA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K080158 is the FDA 510(k) clearance record for LB MEDICAL INFLATABLE TISSUE ELEVATOR/EXPANDER SYSTEM, a class I device, cleared for Lb Medical LLC on under FDA product code FZW (Expander, Surgical, Skin Graft). FDA records list one 510(k) clearance for Lb Medical LLC. As of , FDA records show no recalls naming K080158.

Clearance record

Decision date
Received
(100 days to decision)
Product code
FZW Expander, Surgical, Skin Graft
Regulation
21 CFR 878.4800
Device class
Class I
Review panel
General, Plastic Surgery
Applicant
Lb Medical LLC 901 King St., Suite 200, Alexandria VA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code FZW

Trailing 12 months

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

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