LB MEDICAL INFLATABLE TISSUE ELEVATOR/EXPANDER SYSTEM— 510(k) K080158

Name: FDA 510(k) clearance K080158
Creator: U.S. Food and Drug Administration
Published: 2008-05-02

Substantially Equivalent

Lb Medical LLC

FDA 510(k) clearance K080158 for LB MEDICAL INFLATABLE TISSUE ELEVATOR/EXPANDER SYSTEM, Substantially Equivalent on 2008-05-02. Applicant: Lb Medical LLC. Device class: 1.

Clearance details

Applicant: Lb Medical LLC
Product code: Code FZW
Device class: Class 1
Regulation: 21 CFR 878.4800
Advisory panel: General, Plastic Surgery
Date received: 2008-01-23
Decision date: 2008-05-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Alexandria, VA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code FZW

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K984448 — BIRCOLL BALLOON DISSECTOR1999-01-28
K972109 — SPACEMAKER SURGICALBALLOON DISSECTOR/EXPANDER1997-11-14
K936186 — AESCULAP SKIN GRAFT MESHER1994-03-10
K904265 — INAMED RUIZ-COHEN INTRAOPERATIVE TISSUE EXPANDER1991-03-06
K902349 — SURGITEK INTRA-SPAN INTRAOPERATIVE TISSUE EXPANDER1990-09-05

Adverse events under product code FZW

product code FZW

Malfunction: 3,067
Total: 3,067

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.