Product code FZW— General, Plastic Surgery
AESCULAP SKIN GRAFT MESHER
- Classification name
- Expander, Surgical, Skin Graft
- Device class
- Class 1
- Regulation
- 21 CFR 878.4800
- Advisory panel
- General, Plastic Surgery
- Total cleared
- 8
- First cleared
- Most recent
Market context for product code FZW
FDA has cleared devices under product code FZW between 1987 and 2008, filed by 8 applicant companies. No FDA device recalls reference this product code. Class I devices are low-risk and subject to FDA general controls; many Class I device types are exempt from 510(k) premarket notification.
Clearances per year
- 2008
- 1999
- 1997
- 1994
- 1991
- 1990
- 1988
- 1987
Top applicants under product code FZW
Adverse events under product code FZW
product code FZW- Malfunction
- 3,067
- Total
- 3,067
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recent clearances under product code FZW
- K080158 — LB MEDICAL INFLATABLE TISSUE ELEVATOR/EXPANDER SYSTEM
- K984448 — BIRCOLL BALLOON DISSECTOR
- K972109 — SPACEMAKER SURGICALBALLOON DISSECTOR/EXPANDER
- K936186 — AESCULAP SKIN GRAFT MESHER
- K904265 — INAMED RUIZ-COHEN INTRAOPERATIVE TISSUE EXPANDER
- K902349 — SURGITEK INTRA-SPAN INTRAOPERATIVE TISSUE EXPANDER
- K883303 — MENTOR RAPID-SPAN (TM) TISSUE EXPANDER
- K874276 — CUI, VERSAFIL(TM), STE(TM) TISSUE EXPANDER
Data sourced from openFDA. This site is unofficial and independent of the FDA.