Cleared Traditional

K080158 - LB MEDICAL INFLATABLE TISSUE ELEVATOR/EXPANDER SYSTEM

K080158 is an FDA 510(k) clearance for LB MEDICAL INFLATABLE TISSUE ELEVATOR/E..., manufactured by Lb Medical LLC. The device is a Class 1 General & Plastic Surgery device with product code FZW cleared through the Traditional 510(k) pathway after a 100-day FDA review.

K080158 · Lb Medical LLC · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2008
Decision
100d
Days
Class 1
Risk

K080158 is an FDA 510(k) clearance for the LB MEDICAL INFLATABLE TISSUE ELEVATOR/EXPANDER SYSTEM. Classified as Expander, Surgical, Skin Graft (product code FZW), Class I - General Controls.

Submitted by Lb Medical LLC (Alexandria, US). The FDA issued a Cleared decision on May 2, 2008 after a review of 100 days - within the typical 510(k) review window.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4800 - the FDA general and plastic surgery device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Lb Medical LLC devices

FDA 510(k) Submission Details - K080158

510(k) Number K080158 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 23, 2008
Decision Date May 02, 2008
Days to Decision 100 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
15d faster than avg
Panel avg: 115d · This submission: 100d
Pathway characteristics
Predicate-based equivalence.

FZW Device Classification - Class 1, General Controls

Product Code FZW Expander, Surgical, Skin Graft
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4800
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - FZW Expander, Surgical, Skin Graft

Devices cleared under the same product code (FZW) and FDA review panel - the closest regulatory comparables to K080158.
BIRCOLL BALLOON DISSECTOR
K984448 · Wells Johnson Co. · Jan 1999
SPACEMAKER SURGICALBALLOON DISSECTOR/EXPANDER
K972109 · General Surgical Innovations · Nov 1997
AESCULAP SKIN GRAFT MESHER
K936186 · Aesculap, Inc. · Mar 1994
SURGITEK INTRA-SPAN INTRAOPERATIVE TISSUE EXPANDER
K902349 · Surgitek · Sep 1990
MENTOR RAPID-SPAN (TM) TISSUE EXPANDER
K883303 · Mentor Corp. · Aug 1988