Cleared Traditional

INAMED RUIZ-COHEN INTRAOPERATIVE TISSUE EXPANDER

K904265 · Inamed Development Co. · General & Plastic Surgery
Mar 1991
Decision
169d
Days
Class 1
Risk

About This 510(k) Submission

K904265 is an FDA 510(k) clearance for the INAMED RUIZ-COHEN INTRAOPERATIVE TISSUE EXPANDER, a Expander, Surgical, Skin Graft (Class I — General Controls, product code FZW), submitted by Inamed Development Co. (Carpinteria, US). The FDA issued a Cleared decision on March 6, 1991, 169 days after receiving the submission on September 18, 1990. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4800.

Submission Details

510(k) Number K904265 FDA.gov
FDA Decision Cleared SESE
Date Received September 18, 1990
Decision Date March 06, 1991
Days to Decision 169 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary —

Device Classification

Product Code FZW — Expander, Surgical, Skin Graft
Device Class Class I — General Controls
CFR Regulation 21 CFR 878.4800

Similar Devices — FZW Expander, Surgical, Skin Graft

All 7
LB MEDICAL INFLATABLE TISSUE ELEVATOR/EXPANDER SYSTEM
K080158 · Lb Medical LLC · May 2008
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