Expander, Surgical, Skin Graft
The Expander, Surgical, Skin Graft (product code FZW) is a surgical instrument used to expand harvested skin grafts by creating a mesh pattern, allowing the graft to cover a larger surface area during reconstructive or plastic surgery procedures. It is classified as FDA Class 1, the lowest risk level, requiring only general controls with no premarket notification. The device is regulated under 21 CFR 878.4800 in the General, Plastic Surgery specialty (SU). No special flags apply to this device.
Basic Information
- Product Code
- FZW
- Device Class
- FDA class 1
- Regulation Number
- 878.4800
- Medical Specialty
- General, Plastic Surgery
- Review Panel
- SU
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 8 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K080158 | LB MEDICAL INFLATABLE TISSUE ELEVATOR/EXPANDER SYSTEM | May 02, 2008 | Substantially Equivalent | LB MEDICAL L.L.C. |
| K984448 | BIRCOLL BALLOON DISSECTOR | Jan 28, 1999 | Substantially Equivalent | WELLS JOHNSON CO. |
| K972109 | SPACEMAKER SURGICALBALLOON DISSECTOR/EXPANDER | Nov 14, 1997 | Substantially Equivalent | GENERAL SURGICAL INNOVATIONS |
| K936186 | AESCULAP SKIN GRAFT MESHER | Mar 10, 1994 | Substantially Equivalent | AESCULAP, INC. |
| K904265 | INAMED RUIZ-COHEN INTRAOPERATIVE TISSUE EXPANDER | Mar 06, 1991 | Substantially Equivalent | INAMED DEVELOPMENT CO. |
| K902349 | SURGITEK INTRA-SPAN INTRAOPERATIVE TISSUE EXPANDER | Sep 05, 1990 | Substantially Equivalent | SURGITEK |
| K883303 | MENTOR RAPID-SPAN (TM) TISSUE EXPANDER | Aug 26, 1988 | Substantially Equivalent | MENTOR CORP. |
| K874276 | CUI, VERSAFIL(TM), STE(TM) TISSUE EXPANDER | Dec 02, 1987 | Substantially Equivalent | COX-UPHUFF INTL. |
FEI Numbers
This FDA classification entry is associated with 66 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 66 registration numbers. Click on an entry to view related FDA registrations.