FDA product code FZW: Expander, Surgical, Skin Graft
FZW is the FDA product code for expander, surgical, skin graft. It is a Class I device, regulated under 21 CFR 878.4800 and reviewed by the General and Plastic Surgery panel. FDA has cleared 8 510(k) submissions under FZW, from 8 different applicants. The average 510(k) review took 90 days (median 88). FDA has posted 9 recalls for FZW devices, 1 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Expander, Surgical, Skin Graft |
| Device class | Class I |
| Regulation | 21 CFR 878.4800 |
| Review panel | SU — General and Plastic Surgery |
| Medical specialty | General, Plastic Surgery |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every FZW clearance
Top FZW applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Lb Medical LLC | 1 | 2008-05-02 |
| Wells Johnson Co. | 1 | 1999-01-28 |
| General Surgical Innovations | 1 | 1997-11-14 |
| Aesculap, Inc. | 1 | 1994-03-10 |
| Inamed Development Co. | 1 | 1991-03-06 |
3 more applicants have FZW clearances. See the full list in Caduvo.
Most recent FZW clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K080158 | Lb Medical LLC | LB MEDICAL INFLATABLE TISSUE ELEVATOR/EXPANDER SYSTEM | 2008-05-02 | 100 |
| K984448 | Wells Johnson Co. | BIRCOLL BALLOON DISSECTOR | 1999-01-28 | 45 |
| K972109 | General Surgical Innovations | SPACEMAKER SURGICALBALLOON DISSECTOR/EXPANDER | 1997-11-14 | 162 |
| K936186 | Aesculap, Inc. | AESCULAP SKIN GRAFT MESHER | 1994-03-10 | 77 |
| K904265 | Inamed Development Co. | INAMED RUIZ-COHEN INTRAOPERATIVE TISSUE EXPANDER | 1991-03-06 | 169 |
Recalls for FZW devices
9 product recalls in 4 recall events; 1 initiated in the last five years and 2 still open. Most recent: 2024-01-02.
| Year | Recalls |
|---|---|
| 2017 | 1 |
| 2024 | 1 |
Frequently asked questions
What is FDA product code FZW?
FZW is the FDA product code for expander, surgical, skin graft. It is a Class I device, regulated under 21 CFR 878.4800 and reviewed by the General and Plastic Surgery panel.
What device class is FZW?
Class I, regulation 21 CFR 878.4800. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code FZW?
Across 8 cleared submissions the average was 90 days from receipt to decision (median 88).
Which companies have the most FZW clearances?
Lb Medical LLC (1); Wells Johnson Co. (1); General Surgical Innovations (1); Aesculap, Inc. (1); Inamed Development Co. (1).
Have FZW devices been recalled?
Yes: 9 product recalls across 4 recall events; the most recent began 2024-01-02.
Next steps
- Run an FDA pathway report with predicate devices for product code FZW
- Run a recall and safety report across every FZW manufacturer
- Watch product code FZW for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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